Medical Surgical Nursing Assignment

“A Study to assess the effectiveness of an information leaflet on
awareness and satisfaction of patients undergoing upper
gastrointestinal endoscopy at St. Johns Medical College Hospital
(SJMCH), Bangalore”.
By
LILLYKUTTY M.J (Sr.Lilly Joseph)

Dissertation Submitted To The
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,

KARNATAKA
In partial fulfillment of the requirements for the

degree of
MASTER OF SCIENCE IN NURSING

In
MEDICAL SURGICAL NURSING
Under the guidance of
Prof. Mrs. MADONNA BRITTO M.SC. (N)

Dean of Nursing Faculty of Rajiv Gandhi University of Health Sciences,
Principal,
Head of Medical Surgical Nursing,
St. John’s College of Nursing,
St. John’s National Academy of Health Sciences, Bangalore.
ST.JOHN`S COLLEGE OF NURSING, BANGALORE –34,

KARNATAKA, INDIA
2005
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
DECLARATION BY THE CANDIDATE
I hereby declare that this dissertation entitled “A Study to assess the
effectiveness of an information leaflet on awareness and satisfaction of patients
undergoing upper gastrointestinal endoscopy at St. Johns Medical College Hospital
(SJMCH), Bangalore” is a bonafide and genuine research work carried out
by me under the guidance of Prof. Mrs. MADONNA BRITTO, Dean of
Nursing Faculty of Rajiv Gandhi University of Health Sciences, Principal
& Head of Medical Surgical Nursing of St.John’s College of Nursing
and Dr. ABRAHAM KOSHY, Professor & Head of Gastroenterology
Department, St. John’s Medical College Hospital, Bangalore.
REG.NO: 03NM052
Signature of the candidate
Lillykutty M.J (Sr.Lilly Joseph)

M.Sc. Nursing,
St.John’s College of Nursing
Date: 30.05.2005 Bangalore – 560 034.
Place: Bangalore
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CERTIFICATE BY THE GUIDE
This is to certify that the dissertation entitled “A Study to assess the
effectiveness of an information leaflet on awareness and satisfaction of
patients undergoing upper gastrointestinal endoscopy at St. Johns
Medical College Hospital (SJMCH), Bangalore” is a bonafide and
genuine research work done by Lillykutty M.J (Sr.Lilly Joseph) in
partial fulfillment of the requirement for the degree of Master of Science
in Nursing.
Signature of the Guide: Signature of the Co- Guide:

Prof. Mrs. MADONNA BRITTO M.Sc (N) Dr. ABRAHAM KOSHY,
Dean of nursing faculty of RGUHS, HOD & Professor,
Principal & Department of Gastroenterology,
Head of Medical Surgical Nursing St.John’s Medical College-
St.John’s College of Nursing, Hospital
Bangalore – 560 034 Bangalore – 560 034
Date:30.05.2005 Date: 30.05.2005

Place: Bangalore Place: Bangalore
-3-
ENDORSEMENT BY THE HOD, PRINCIPAL / HEAD OF THE
INSTITUTION
This is to certify that the dissertation entitled “A Study to
assess the effectiveness of an information leaflet on awareness and
satisfaction of patients undergoing upper gastrointestinal endoscopy at
St. John’s Medical College Hospital (SJMCH), Bangalore” is a
bonafide research work done by Lillykutty M.J (Sr. Lilly Joseph) under
the guidance of Prof. Mrs. MADONNA BRITTO, Dean of Nursing
Faculty of Rajiv Gandhi University of Health Sciences, Principal & Head
of Medical Surgical Nursing of St. John’s College of Nursing.
Signature of the Principal:

Prof.Mrs. MADONNA BRITTO M.Sc (N)
Dean of Nursing Faculty of RGUHS,
Head of Medical Surgical Nursing
Date:30.05.2005 St.John’s College of Nursing,
Place: Bangalore Bangalore – 560 034
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COPY RIGHT
Declaration by the candidate
I hereby declare that the Rajiv Gandhi University of Health Sciences,
Karnataka shall have the rights to preserve, use and disseminate this
dissertation /thesis in print or electronic format for academic /research
purpose.
Date:30.05.2005 Signature of the candidate

Place: Bangalore Lillykutty M.J (Sr. Lilly Joseph)
M.S c.Nursing,
St.John’s College of Nursing
Bangalore – 560 034
©Rajiv Gandhi University of Health Sciences, Karnataka
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ACKNOWLEDGEMENT
Dedicated to God Almighty

Not only this humble piece of academic work
But also my entire life
For to Him I am bounded forever.
My profound gratitude
To
Prof. Mrs. MADONNA BRITTO

DEAN OF NURSING FACULTY OF RGUHS
PRINCIPAL
HEAD OF MEDICAL – SURGICAL NURSING
&
MY GUIDE
I place on record my deep sense of appreciation and obligation for the untiring
efforts and constant vigilance put in by my guide who is the moving spirit behind
this academic work and whose dedication and personal interest to this cause is
unmatched.
My appreciation and thanks
To
Dr. ABRAHAM KOSHY

MY CO–GUIDE
HOD & PROFESSOR
GASTROENTROLOGY DEPARTMENT
ST.JOHN’S MEDICAL COLLEGE HOSPITAL
I am particularly appreciative of his valuable suggestions, helpful discussions, honest

opinions, diligence in proof-reading and assistance rendered in the selection of research
methodology, materials, analysis of data and above all for his positive influence on my
learning.
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My special thanks
To
Rev. Fr. THOMAS KALAM, DIRECTOR, SJNHS
Rev. Fr. SEBASTIAN, ADMINISTRATOR, SJMCH
Dr. MARY OLLAPPALLY, MEDICAL SUPERINTENDANT, SJMCH
REV.SR.RIYA, NURSING SUPERINTENDANT, SJMCH
My heart felt thanks
To
Miss. Mildred Rani, VICE PRINCIPAL for her helpful discussions.
Sr. Suma Kuttickal, Addl. VICE PRINCIPAL for her sisterly support and prayers
I remain with folded hands
Before
Prof. Mrs. H.Lalitha, MSc Coordinator
For her commitment, professionalism and tireless efforts in keeping track of the
number of activities involved in the production of this work.
I remain indebted
To
Following teachers from whom I learnt Nursing Research and Bio-statistics:
Prof. Mrs. Mary Ann Charles,
Prof. Mrs. Preethy D’Souza,
Prof. Mrs. Jasmine Benny

&
Dr. Rangappa.
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My special thanks are due to the team of dedicated faculty at SJCON for their
generous contribution of time, effort, knowledge and discussions in refining this
study.
Special word of thanks and appreciation to Prof.Mrs.Jasmine Benny for her

generous help and commitment to the completion of this study.
I am thankful to all the experts for critical evaluations of the Research tools and their
valuable comments and suggestions.
I acknowledge the liberal library assistance by the following individuals:
Mr. Anand Raj, CHIEF LIBRARIAN, Mr. John, ASST. LIBRARIAN,

Mrs. Vijayalakshmi,
Mrs Nirmala and other Library assistants.
I owe depth of gratitude and obedience
To
REV.SR.PAULINE JOSEPH, my Provincial Superior,
Sr. Onerine, my SUPERIOR and all the sisters of my dear congregation for they
prepared me for the Mission of Charity.
.
This blanket of acknowledgement is for the following persons for they made this
work possible:
• Dr. Mohammad, Associate professor, SJMC.
• Sr. Annie Sheela, CTC. MD, DM for her helps in the analysis of the data.
• Mr.Kurian John & Team, Browsing Centre, SJMC- for printing the text.
• Mr.Jinu James Kurian MCA, The computer graphic expert.
• My beloved parents, brothers and sisters for their prayers, sacrifices and
concerns.
• Dr.Sandeep, The editor
• Endoscopists, supervisors and staff members of endoscopy unit and inpatient
departments of SJMCH.
• All the study participants and their care givers
• My companions.
I humbly acknowledge that inspite of my best efforts at perfection, element of human

errors is still likely to occur which my teachers and friends are welcome to point out since
that would help me in improving my learning further.
Lastly, it is the work of the Lord; Let His Name be glorified for ever.
Lillykutty M.J. (Sr. Lilly Joseph)
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LIST OF ABBREVIATIONS
ABBREVIATIONS EXPANSIONS
Addl Additional
ANOVA Analysis of Covariance
CI Confidence Interval
CL Confidence Limit
CON Control
ERCP Endoscopic Retrograde Cholangio-
Pancreatography
EXP Experimental
f Frequency
G.I Gastrointestinal
HOD Head Of the Department
IEC Information, Education and Communication
IP Inpatients
KS Kolmogorov and Smirnov
MD Mean Difference
N(n) Sample
OP Outpatients
OPD Out Patient Department
RGUHS Rajiv Gandhi University of Health Sciences
SD Standard Deviation
SEM Standard Error of the Mean
SJCON St.John’s College of Nursing
SJMC St.John’s Medical College
SJMCH St.John’s Medical College Hospital
UGIE Upper gastrointestinal endoscopy
2
X Chi-Square test
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ABSTRACT
Background:
Written patient information materials can be valuable communication tools for
reinforcing the verbal message, especially for those health services where patients are
in the hospital for short times. Though there are information leaflets and booklets
provided for patients undergoing upper gastrointestinal endoscopy in India, no
published research studies are available on the quality and effectiveness of this
information.
Objectives:
1. To compare the awareness of patients in the control and experimental groups
before undergoing upper gastrointestinal endoscopy.
2. To compare the satisfaction with the actual experience at the endoscopy unit in
the control and experimental groups after undergoing the procedure.
3. To determine the association between the awareness and selected baseline
variables.
Methods:
An outcome research with prospective, randomized, controlled, post test only
experimental design with two data collection points after the leaflet intervention. The
population studied was patients undergoing diagnostic upper gastrointestinal
endoscopy. The sample size consisted of 200 patients, 100 each in group. Two self
report quantitative questionnaires were used for data collection. The content validity
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and reliability of the instruments were established and piloted in 20 patients before the
main study. Ethical approval to undertake this study was granted prior to pilot study.
Results:
The mean awareness score of experimental group was 17.55 +2.9 (M + SD)
compared to the control group 7.16 + 3.5 (M + SD). (P<0.0001).The mean
satisfaction score of experimental group was 13.44 + 3.9 (M + SD) compared to the
control group 10.54 + 3.9 (M + SD; P<0.0001).
Interpretation:
The leaflet made a commendable contribution in increasing awareness of
experimental group regarding upper gastrointestinal endoscopy and succeeded to get a
high satisfaction in the area of information provided when compared to control group.
Conclusion:
Provision of a well designed leaflet improves awareness and satisfaction of
patients undergoing upper gastrointestinal endoscopy compared to informal verbal
information.
KEY WORDS:
Effectiveness; Information; Leaflet; Awareness; Satisfaction; Upper gastrointestinal
endoscopy.
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TABLE OF CONTENTS
CHAPTERS CONTENTS PAGES
1. INTRODUCTION 1 -3
• Need for the study 4 - 11
2. OBJECTIVES
• Statement of the problem 12
• Objectives of the study 12
• hypothesis 12
• Operational definitions 12 -14
• Assumptions 14-15
• Delimitations 15
• Projected outcome 15
• Conceptual Framework of the study 17 – 20

3. REVIEW OF
LITERATURE
• Introduction 21
• Diagnostic upper gastrointestinal
endoscopy 22 – 27
• Benefits of information giving 27 – 31

• Benefits of increasing awareness in
patients 32 – 34
• Information leaflet as a method of
providing information 34 – 35
• Literacy and education in India 35 – 37
• Growth of interest in patient education 37 – 38
• Dimensions of satisfaction 38 – 39
39 – 42
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• Psychological aspects of care
• Satisfaction as an outcome measure 42 – 43
• Effectiveness and outcome research 43 – 44
• Conclusion 44
4.METHODOLOGY
• Research approach 45
• Research Design 47
• Variables under study 47
• Setting of the study 47 – 48
• Population 48
• Sample size 49
• Inclusion criteria for sampling 49 – 50
• Exclusion criteria for sampling 50
• Sampling technique 50 – 51
• Instruments 54 – 59
• Content validity 59
• Reliability 60
• Pilot study 60 – 61
• Data collection of the main study 63 – 64
• Ethical considerations 65
• Data Analysis Plan 67
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5. RESULTS
• Organization of the study findings 69
1. Description of demographic variables 70 – 75
2. Comparison of two groups’ variability 76

for homogeneity
3. Comparison of awareness of subjects on

upper G.I endsoscopy 77 – 79
4. Comparison of satisfaction of subjects

with the actual experience at the 80 – 88
endoscopy unit.
5. Association between awareness and

selected baseline variables of both 89 – 93
experimental and control groups
6. DISCUSSION
1. Findings related to demographic 94 – 96
variables of subjects
2. Findings related to awareness of 97 – 102

subjects on upper gastrointestinal
endocopy
3. Findings related to satisfaction of 102 – 107

subjects with the actual experience at
the endoscopy unit
4. Findings related to the association of 107 – 110

awareness and baseline variables of
subjects
7. CONCLUSION 111 – 112
8. SUMMARY • An overview of research process 113 – 114
• Major findings of the study 115– 117
• Implications of the study 117– 119
• Recommendations 119– 120
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• Limitations of the study 120
• Personal learning 120
9. BIBLIOGRAPHY
10. ANNEXURES
A • Letter seeking permission to conduct

study
B • Letter seeking permission to validate

tool
C • Letter requesting experts to compute the

content validity
D • List of experts who validated the tool
E • Suggestions and corrections of experts
F • Certificate of validation
G • Informed consent from study

participants in English
H • Informed consent from study

participants in Kannada
I • Informed consent from study

participants in Tamil
J • Informed consent from study

participants in Telugu.
K • Information leaflet on upper

gastrointestinal endoscopy in English.
L • Information leaflet on upper

gastrointestinal endoscopy in Kannada.
M • Information leaflet on upper

gastrointestinal endoscopy in Tamil.
N • Information leaflet on upper

gastrointestinal endoscopy in Telugu
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O • Patient Instrument -1 in English
P • Patient Instrument -1 in Kannada
Q • Patient Instrument -1 in Tamil
R • Patient Instrument -1 in Telugu
S • Patient instrument -2 in English
T • Patient instrument -2 in Kannada
U • Patient instrument -2 in Tamil
V • Patient instrument -2 in Telugu
W • Blue print of patient instrument-1
X • Answer kees of awareness

questionnaire.
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LIST OF TABLES
TABLE TITLE PAGES

NO.
1 ¾ Descriptive and inferential statistics used for the study. 67
2 ¾ Comparison of two groups’ variables for homogeneity. 76
3 ¾ Comparison of awareness of subjects on upper 77

gastrointestinal endoscopy after the administration of
leaflet measured before undergoing the procedure.
4 ¾ Comparison of awareness scores of experimental and 78

control groups determined by Mann-Whitney Test.
5 ¾ Comparison of content wise awareness scores of subjects 79

on upper gastrointestinal endoscopy.
6 ¾ Comparison of satisfaction of subjects with the actual 80

experiences at the endoscopy unit measured after
undergoing the upper gastrointestinal endocopy.
7 ¾ Comparison of satisfaction scores of experimental and 81

control subjects determined by Mann- Whitney Test.
8 ¾ Association between the awareness and satisafaction of 82

experimental and control groups. (Within group
comparisons).
9 ¾ Agreement and disagreement among subjects on time 83

spent waiting for the procedure, actual endoscopy
procedure measured after undergoing upper
gastrointestinal endoscopy.
10 ¾ Agreement and disagreement among subjects on care 84

during and after the procedure, and information provided
measured after undergoing upper gastrointestinal
endoscopy.
11 ¾ Agreement and disagreement among subjects on overall 85

care and their satisfaction to refer friends and relatives to
the same facility measured after undergoing upper
12 ¾ Responses of experimental group on satisfaction with the 86

content of the leaflet information measured before
undergoing upper gastrointestinal endoscopy.
13 ¾ Correlation of before and after opinion on leaflet 87
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information by experimental group.
14 ¾ Association between age and awareness of experimental 89

and control groups.
15 ¾ Association between sex and awareness of experimental 90

and control groups.
16 ¾ Association between previous endoscopy experience and 91

awareness of experimental and control groups.
17 ¾ Association between inpatients Vs outpatients and 91

awareness of experimental and control groups.
18 ¾ Association between the awareness and education of 92

experimental and control groups.
19 ¾ Association between occupation and awareness of 93

experimental and control groups.
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LIST OF FIGURES
FIGURE TITLE PAGES

NO.
1 The conceptual framework for the present study based 16

on King’s Theory of Goal Attainment.
2 Schematic representation of research design 46
3 Floor plan of gastrointestinal endoscopy unit. 48
4 The flow chart of sampling technique. 52
5 Flow diagram of leaflet and patient instrument-1 53

development
6 Spring model of leaflet information. 56
7 Data collection stages. 62
8 Data analysis plan. 66
9 The percentage distribution of subjects according to 70

their age in experimental groups
10 The percentage distribution of subjects according to 70

their age in control groups
11 The percentage distribution of experimental subjects 71

according to their sex

according to their sex
13 The percentage distribution of experimental and control 72

groups according to their education
14 The percentage distribution of experimental and control 73

groups according to their occupation

according to their previous endoscopy experience

according to their previous endoscopy experience
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17 The percentage distribution of inpatients & outpatients 75
in experimental groups
18 The percentage distribution of inpatients & outpatients 75

in control groups
19 Before and after comparison of satisfaction with the 87

leaflet information elicited from the experimental
group of subjects.
20 Adequacies and appropriateness of leaflet information 88

in relation to the actual procedure as perceived by the
experimental group of subjects.
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1. INTRODUCTION
Information, Education and Communication (IEC) are well recognized for
accelerating health awareness in individuals, families and communities. The success
of any awareness programme depends mainly on the voluntary and widespread
acceptance of the concept, benefits and processes of that programme1. The efforts
undertaken by government and non-governmental institutions and projects through
mass education and media activities have resulted in creating 100% awareness among
the people about various issues related to healthy living, medical, surgical, nursing
and diagnostic procedures2. By the constant and continuous utilization of educational
methods and media, it has become possible to remove the deep-rooted attitudes,
beliefs, perceptions and misconception that were detrimental to the acceptance of
efforts undertaken towards increasing awareness regarding health and illness related
subjects. Strategies of different types have been evolved and implemented with a view
to achieving behavioral and attitudinal changes and to convert the existing and
acquired wide spread of awareness into acceptance and satisfaction3.
As pointed out previously, health literacy is the means by which holders of
knowledge can make that knowledge understandable and usable for the receiver.
According to Healthy People 2010, the health literacy is “the degree to which
individuals have the capacity to obtain process and understand basic health
information and services for appropriate health decision.” Health awareness arises
from a convergence of education, health services, social and cultural factors, and
bring together research and practice from diverse fields4. In the opinion of past
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researchers, generating awareness is absolutely essential for creating an anxiety free
atmosphere for clients at the designated healthcare setting5. Previous researches6,7
have featured that education, coping skills, relaxation techniques and a combination
of these including music, have decreased anxiety in patients across many settings.
Therefore information giving in a limited time requires the practitioner to be able to
prioritize and focus on what is important for the client8.
Above all, the era of change is upon healthcare, and whatever the final
outcome may be, patient care, perception, expectation and satisfaction must be at the
forefront of any service provided by healthcare institutions. Today the emphasis is on
consumer friendliness, provision of a complete, up-to-date and concise coverage of
information in a clear language9. Consumer oriented healthcare has emerged as a
strategy to disseminate information to consumers with the goal of enabling them to
make informed choices. The provision of information before medical or surgical
procedures has two goals: to provide a mechanism by which patients can participate
in treatment decisions with full understanding of the factors relevant to their proposed
care, and to improve post-operative or post procedure recovery and reduce situational
anxiety10. As a result, informed signed consent is now a legal necessity for all medical
and surgical procedures. To obtain a legally safe informed consent requires that the
patient has a ‘substantial understanding’ of the proposed procedure and that the
person obtaining the informed consent has sufficient knowledge to explain the nature
of the procedure to the patient11.
As ever, the salient feature of medical and nursing profession requires
physicians not only to perform to the best of their abilities, but also to do no harm (the
oath of Hippocrates) and nurses to do all in their power to maintain and elevate the
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standard of their profession (the pledge of Nightingale)12. This approach to medicine
and nursing is seemingly intuitive and although physicians and nurses embrace this
philosophy, there have been ever increasing demands to develop methodologies to
measure and verify our performance objectively to our patients, payees, accrediting
agencies, regulatory bodies and also to ourselves. So consumers’ information about an
episode of care lets providers know what is important to the public about their
medical and nursing care13.
Surprisingly, changes have taken place in the arena of nursing profession too,
incorporating rapidly emerging advances in diverse fields of health and sciences, to
keep pace with the latest. The recent profusion of new nursing roles such as Clinical
Specialists, Nurse Practitioner, Advanced Nurse Practitioner, Higher Level
Practitioner and Nurse Consultant extended the scope of professional practice. One of
the highlights of these changes is in the field of gastroenterology14. The
Gastroenterology Advanced Practice Nurse performs history and physical
assessments, orders diagnostic studies, determines medical and nursing diagnoses,
prescribes and evaluates pharmacological and other therapeutic regimens, manages
follow up care, evaluates patient outcomes. Client teaching and information on
medical procedures and care organization is recognized as one of the most important
tasks for the nurse15.
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Need for the study
“The gem cannot be polished without friction, nor man perfected without trials.”
(Chinese proverb)
The need for efficient, evidence-based patient education has been growing
steadily concomitant with the recent changes in health management systems, the
ongoing development of new technologies, and the spiraling costs of healthcare16.
Over the past 30 years, many medical and nursing researches have shown that giving
information to patients prior to surgery and investigations reduces stress and anxiety
associated with them17. There are empirical evidences that patient education is
important in ensuring quality of care, safety, and cost effectiveness. However, some
researches have consistently proved that patients are frequently dissatisfied with the
quality and quantity of information provided by nurses and other health professionals.
Therefore, recent studies have focused on patients’ perceptions of their information
needs, enabling them to make informed decision regarding treatment options and in
increasing patient satisfaction18.
Today, endoscopy as a discipline has made great strides through the
introduction of new technology and the application of technology to traditional issues
in gastroenterology19. The introduction of new technology has progressed along many
fronts, including standard endoscopes and new instruments. The growing use and
complexity of endoscopy procedures in Gastroenterology units has increased the need
for good patient preparation20. A study21 which evaluated the cost-effectiveness of a
patient education program of endoscopic procedures at a gastroenterology department
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of Israel using a prospective, randomized, controlled design on 142 patients aged 18-
90 years referred for an endoscopy procedure concluded that pre-endoscopy patient
education programs apparently increase patient compliance; thereby decreasing both
the need for repeated examinations and their attendant costs.
Gastroenterologists and gastroenterology nurses are required to obtain
informed consent before undertaking any endoscopic examination. Published data
indicate that in practice there are many deficiencies in this process. The European
Society of Gastrointestinal Endoscopy (ESGE) studied22 the quality of information
given to patients before endoscopic procedures and a structured questionnaire was
sent to representatives of ESGE regarding the quality of informed consent. The
response rate was 59% (26/44). The endoscopist is responsible for giving the required
information in only 23.1% (6/26) of countries. Although information about the
procedure is given to patients in 96% of the responding countries, in only 77% is there
sufficient time for the patients to ask questions about the nature of the procedure. In a
patient–opinion survey23 on informed consent for gastrointestinal endoscopy
conducted in September 2004 on 11,639 patients at Three River Endoscopy Center in
Israel, 66% of the patients were satisfied with the written consent process. Only 10%
considered that the written consent process altered their trust in their doctor. 98% of
the patients were satisfied with the consent form, 97% felt it was clear and
comprehensive and 80% of the patients felt it was reassuring. A prospective study24 in
Austria interviewed 200 patients investigating the success of preoperative information
on Laparoscopic Cholecystectomy. Ninety-seven percentages (97%) indicated to wish
detailed information, 84% indicated a high level satisfaction with the presented
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information, while the levels of knowledge concerning indications for surgery and
procedures were satisfactory in 85 and 51% respectively.
The provision of verbal information although, important and in practice, has
been shown to have limitations because patients frequently forget much of the
information they are told. The provision of written information is one way that the
information needs of patients can be improved. Studies25, 26 have showed that written
information given has several advantages. Firstly, the provision of written information
provides a back-up system in cases where patients are not provided with information
or cannot recall information. Secondly, written information enables people to access
the information they want at the time they want it. Thirdly, written information may
be useful in clarifying verbal information and if presented clearly may be open to less
misinterpretation than verbal information. A survey27 evaluated the effectiveness of
information leaflet for patients undergoing colonoscopy at the gastroenterology unit
of Florence. The leaflet together with a multiple choice questionnaire aimed at
evaluating client’s satisfaction with the information provided was distributed to 100
clients undergoing a colonoscopy over a two-month period in 1998. The results of the
survey suggest that the leaflet has been instrumental in client learning about the
procedure, as shown by the high positive satisfaction response provided to the
questionnaire. The written information is a successful addition to verbal information
only if it is done well. This means it must be given to all patients and that it must be
clearly presented in understandable languages and the information must be complete,
detailed, and personalized according to the client culture and learning capacity. At
present, all the patients booked for colonoscopy receive the booklet in their homes28.
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A postal survey29 was conducted in London to investigate the practicability
and patient acceptability of postal information and consent booklet for patients
undergoing outpatient gastroscopy. An audit of 168 patients was used to test reaction
to the booklet and the idea of filling in a form before coming to the hospital; 155
patients (92.2%) reported the information given in the booklet to be “very useful” and
all reported it to be “clear and understandable”. The study concluded: A specially
designed patient information booklet with integral consent form is accepted by
patients, and improves the level of understanding prior to the investigation.
Previous researches have shown that information giving relieves anxiety and is
considered an act reassurance. Endoscopy nurses can help to relieve such anxieties,
using their skills to deep the patient safe and comfortable and explaining the coming
procedure in terms the patient can understand. Clement and Melby30 determined the
amount and type of information given to patients before, during and after undergoing
gastroscopy investigations. There were statistically significant differences between
the information acquired by younger and older patients prior to the procedure and
nurses appeared to be the most important source of information for older patients
while the information leaflet was perceived as the most important source of
information for younger patients. Another survey31 investigated the information
provided to patients undergoing gastroscopy procedures in Northern Ireland. Patients
received most of the procedural information from nurses, and they recognized the
importance of providing sensory information. Patients were generally satisfied with
the information provided.
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Another area of growing interest in healthcare is patient satisfaction. There is
an abundance of literature regarding patient satisfaction and the factors that increase
satisfaction. Patient experiences of healthcare have become a central focus for
researchers, policy makers, clinicians and patient groups in many countries and
survey of patient experiences have become increasingly common internationally. The
measurement of patient satisfaction has been encouraged by a growing consumer
orientation in heath care, especially since it yields information about consumers’
views in a form, which can be used for comparison and monitoring32.
A paper presented at the Plymouth University of England33 indicated
considerable differences between satisfied and not satisfied clients in the service
received and their perception. Patient satisfaction relate clearly to the use of
interpersonal skills such as those of communication, empathy, listening, openness and
genuineness. A descriptive correlation study34in North Carolina examined the
satisfaction levels of patients in relation to nursing care in the emergency department.
The majority of scores related to satisfaction with nursing care ranged from ‘very
satisfied’ to ‘satisfied’ with their overall nursing care. Highest satisfaction scores were
indicated for overall caring and compassion (75%), skill with medications and
treatment (74%). In a satisfaction survey35 of patients who had a gastrointestinal
procedure in 2002, it was found that patient satisfaction is generally quite high, with
ratings of nurses and physicians topping the list. Another study evaluated36 the effect
of pre-procedure education on patient satisfaction and cooperation during an
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedure in Thailand.
Forty-five patients with a mean age of 58 years participated in the study. Effective
patient cooperation was achieved and all subjects were satisfied with the educational
- 28 -
process and the ERCP team. These findings suggest that pre-procedure education is a
cost-effective intervention to enhance patient cooperation and patient satisfaction.
Reflecting on several foreign studies on the information needs of patients
during their health and illness, the investigator was interested, above all, in two
studies on information provided to patients prior to gastroscopy procedures, published
in the Journal of Clinical Nursing, 199830 and 200331. The investigator searched for
the studies of same nature done in India. From the available published literature it is
evident that vast quantities of written patient information are produced and are freely
available in most of the major hospitals of India. Although there are information
leaflets and booklets provided for the patients, no published research studies are
available on the quality, management and effectiveness of these information resources
to patients undergoing upper gastrointestinal endoscopy. To find out more about this
interesting development, the investigator visited the endoscopy unit of St. John’s
Medical College Hospital (SJMCH) where nearly 5000 of investigations were
performed on the gastrointestinal tract in the year 2003-2004. The investigator made a
detailed study of information given in the endoscopy unit of St. John’s Medical
College Hospital. The departmental statistics of the years 1995–2004 February
showed that on an average 350 patients per month have undergone upper
gastrointestinal endoscopy at St John’s Medical College Hospital. Upper
gastrointestinal endoscopy is a commonly used investigation in St. John’s Medical
College Hospital, for the assessment and evaluation of gastrointestinal problems.
Even though there are a number of patients undergoing upper gastrointestinal
endoscopies, the information sheet provided is ‘the request for endoscopy form’
which has limited information in English and Kannada.
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The gastrointestinal endoscopy unit of SJMCH caters to patients from all
walks of life, who speak different languages like Kannada, Tamil, Telugu and
English. The unit is staffed apart from endoscopists with a senior nurse, a junior staff
on rotation for every 15 days, two nursing assistants and a typist. Those working in
endoscopy units have long recognized that a patient’s psychological reactions to
endoscopic procedures have a major influence on their tolerance for the examination.
However, the atmosphere of this busy unit is not the best environment in which to
give orally new and complex information about an unknown procedure. As a result
patients receive fractions of information from the busy staff. The endoscopy team
expressed that their patients often view this procedure with anxiety and fear and a
majority of them experience some degree of stress as they undergo upper
gastrointestinal endoscopy procedures. So the need to provide relevant and
understandable information is vital because incomplete information is more confusing
and alarming.
In St. John’s Medical College Hospital (SJMCH) no study has been done to
assess the information needs of patients undergoing upper gastrointestinal endoscopy
or the effectiveness of the present process of information giving. Therefore the
investigator felt that the timing of when information is provided, the form in which it
is presented, the content and the readability of written information, choice of
information givers and satisfaction with the information provided are all important
issues that must be addressed. Information to patients must be presented in a language
that they understand. Patients should be provided with information about their
procedure prior to their arrival at the unit. A written information leaflet would allow
the patients to assimilate the information in familiar surroundings and give them the
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opportunity to think of any questions they may want to ask before undergoing the
procedure. It is the responsibility of the nurse who is either giving or being asked for
information, to structure information giving in such a manner that clarity is assured
for each individual patient. Nurses, in particular, are viewed as appropriate health
professionals to provide information to patients, both because they are accessible and
because patients perceive them to have adequate knowledge to provide information.
To address the above points the investigator felt that it is vital to develop a
new set of information leaflet on upper gastrointestinal endoscopy in Kannada, Tamil,
Telugu and English. The effectiveness of newly designed leaflet information in terms
of awareness and satisfaction will be evaluated using a prospective, randomized,
controlled, post test only experimental research design.
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2. OBJECTIVES
STATEMENT OF THE PROBLEM
A study to assess the effectiveness of an information leaflet on awareness and
satisfaction of patients undergoing upper gastrointestinal endoscopy at St. John’s
Medical College Hospital (SJMACH), Bangalore.
OBJECTIVES OF THE STUDY
before undergoing upper gastrointestinal endoscopy measured by a structured
patient questionnaire.
the control and experimental groups after undergoing upper gastrointestinal
endoscopy measured by a structured patient questionnaire.
variables of both control and experimental groups.
HYPOTHESIS
The mean post test awareness score obtained from patients who receive a
newly designed information leaflet on upper gastrointestinal endoscopy will be
significantly higher than the mean post test awareness score obtained form the
patients who did not receive a leaflet on upper gastrointestinal endoscopy as measured
by a structured patient questionnaire at 0.5 levels.
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OPERATIONAL DEFINITIONS
Effectiveness: In this study the effectiveness refers to the outcome of an
information leaflet on upper gastrointestinal endoscopy in respect to changes in the
experimental group of patients with the following responses:
a) an increase in awareness
b) a positive correlation between the written information and satisfaction with the
actual procedure of upper gastrointestinal endoscopy as perceived by patients of
experimental group.
Information: In this study information means selected written contents
prepared by the investigator based on the identified learning needs of patients on
selected areas of upper gastrointestinal endoscopy procedure written in English and
then translated into Kannada, Tamil and Telugu. The selected areas included in the
said information are as follows:
a) Concept of upper gastrointestinal endoscopy
b) Care before the procedure
c) Care during the procedure
d) Care after the procedure
Leaflet: In this study leaflet refers to a printed sheet of three folds with
concise, precise and standardized explanation and instructions about the procedure of
upper gastrointestinal endoscopy designed by the investigator after consulting
endoscopists, college of nursing faculties, endoscopy nurses, patients who had upper
gastrointestinal endoscopy and based on the review of literature.
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Awareness: In this study awareness refers to the patent’s knowledge of what,
why and how upper gastrointestinal endoscopy is carried out, the sensations that they
may expect during and after procedure and what is expected of them before, during
and after the procedure measured by a structured patient instrument-1.
Satisfaction: In this study satisfaction refers to a reflection of how the
patients of experimental and control groups perceived the episode of care at the
endoscopy unit in relation to leaflet information on upper gastrointestinal endoscopy
measured by a structured patient instrument-2.
Patient: In this study patient refers to an individual who seeks/receives
medical and nursing care at St. John’s Medical College Hospital and is advised to
undergo an upper gastrointestinal endoscopy for diagnostic purposes.
Upper gastrointestinal endoscopy: In this study upper gastrointestinal
endoscopy refers to a diagnostic procedure where a thin, flexible tube with a bright
light, which is attached to a TV camera (endoscope), is passed through the mouth of
the patient by a Gastroenterologist to view the lining of esophagus, stomach and
duodenum.
Baseline variables: In this study, baseline variable refers to age, gender,
education, occupation, previous endoscopy, inpatients Vs outpatients.
ASSUMPTIONS
1) Patients undergoing invasive procedures like upper gastrointestinal endoscopy
wish to have awareness in this procedure.
2) Patients may have some basic information about upper gastrointestinal
endoscopy that can be supplemented.
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3) Patients are generally willing to receive relevant information so as to cope with
the procedure.
4) Written information will provide ready reference about expected behavior of
patient as before, during and after the procedure and thus enhances the
satisfaction level.
5) An information leaflet enables the patients to know about the procedure in a
systematic way.
DELIMITATIONS
1) Study is limited to patients undergoing diagnostic upper gastrointestinal
endoscopy between the age of eighteen and sixty.
2) Generalization from the study is limited to patients undergoing upper
gastrointestinal endoscopy at a tertiary care hospital (SJMCH).
PROJECTED OUTCOME
Firstly, this study will support other researches, which have indicated that one
way of facilitating improved information giving is through the greater use of written
information. Secondly, this study will lead to a major change in the quality of
information giving at the endoscopy unit of St. John’s Medical College Hospital,
producing a leaflet on upper gastrointestinal endoscopy that would be more
informative and attractive in four languages: Kannada, Tamil, Telugu and English and
which would prove more satisfactory to patients. Thirdly, nurses and the other
members of the health team would deliver information through well-designed patient
information leaflet in conjunction with oral information provision. Fourthly, the
endoscopists and endoscopy nursing team would identify the most efficient and
effective service and would become sensitive to patient’s values.
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Figure-1: The conceptual framework for the present study based on King’s Theory of goal attainment
Perception Communication Interaction Transaction
Patients’ Concern Mutual goal setting

Exploration of Experimental
information on upper Group Goal Outcome
GI Endoscopy Measurement
Informal decision
making Post Test – 1
Provide (Awareness)
information on Leaflet
upper GI Information Upper GI Endoscopy
Endoscopy
Post Test – 2
Nurses’ Concern Process the (Satisfaction)
information into
Generate Awareness a leaflet
Informed Consent
Control Group
Enhance satisfaction
Feed Back
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CONCEPTUAL FRAMEWORK
The conceptual framework for the present study was based on Imogen King’s
theory of goal attainment. King’s conceptual framework for nursing (1981) consists of
three interacting open systems: (1) individual as personal system. (2) two or more
individuals forming inter-personal system and (3) larger groups, with common interests
forming social system. King’s theory of goal attainment focuses on interpersonal system
and the interaction that take place between individuals, specifically in the nurse-client
association, the dyadic phase 37- 40.
The theory describes the nature of nurse’s interaction with client to establish goals
mutually and to explore and agree on means to achieve goals. Mutual goal setting is
based on nurse’s assessment of client’s various problems and disturbances in health, their
perception of problems, and their sharing information to nurse towards goal attainment.
During patient-health personal interaction, acknowledgement and verbalization of
patient’s perceived need can occur.
Concepts integral to King’s conceptual framework and most applicable to present
study include perception, communication, interaction and transaction. Nurses could
utilize communication and interaction to provide patients with information and education
necessary to increase awareness on upper gastrointestinal endoscopy before undergoing
the procedure and satisfaction after undergoing the procedure. These concepts provide a
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framework to structure the development of a written communication for patients
undergoing upper gastrointestinal endoscopy in an interactive process.
Perception: Perception is presented as the major concept of a personal system,
the concept that influences all behaviors or to which all other concepts is related.
Perception was defined as “each person’s representation of reality”. Perceptions are
related to past experiences, concept of self, socio-economic groups, biological
inheritance, and educational background. King further discusses perception as a process
in which data obtained through the sense and from memory are organized, interpreted and
transformed.
In this study, the investigator interacted with patients who had upper
gastrointestinal endoscopy, with patients who were posted for upper gastrointestinal
endoscopy during need assessment period and with endoscopy medical and nursing team.
The nurse and the patients perceived the need for increased awareness to make an
informed choice regarding upper gastrointestinal endoscopy before undergoing the
procedure.
Communication: Communication is defined as “a process whereby information
is given from one person to another either directly in face-to –face meetings or indirectly
through telephone, television or the written word”. Communication is the information
component of the interaction. Perception is action oriented in the present and based on
the information that is available.
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In this study, the information component of interaction and the mutual goal setting
was established by a set of newly designed information leaflet on upper gastrointestinal
endoscopy. The key areas of information are (1) concepts regarding upper gastrointestinal
endoscopy (2) care before the procedure (3) care during the procedure (4) care after the
procedure.
Interaction: king defines interaction as a process of perception and
communication between persons and environment and between persons and persons
represented by verbal and nonverbal behaviors that are goal oriented.
In this study the interaction takes place between experimental group patients and
the new set of information leaflet on upper gastrointestinal endoscopy. The leaflet brings
concise, precise and standard information and instructions to exchange with patients
undergoing upper gastrointestinal endoscopy.
Transaction: Transaction is the valuation component of interaction. It is the
observable behavior of human beings interacting with environment. Transaction leads to
goal attainment. It is an outcome measure of interaction.
In this study the result of interaction between leaflet and experimental group of
subjects will be measured by post test-1 before undergoing upper gastrointestinal
endoscopy. If the goals are attained, satisfaction will occur and that will be measured by
post test-2. The opinion regarding leaflet information will be solicited from the
experimental group of subjects before and after undergoing the procedure. The nurse will
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determine the correlation between the leaflet information and the actual procedure as
perceived by the experimental group of patients.
To conclude communication and interaction takes place indirectly between nurse
and patients undergoing upper gastrointestinal endoscopy through the medium of written
leaflet information and if “perceptual accuracy” exists in the patients, transaction is the
outcome which is expressed in terms of an increase in the awareness regarding the
procedure and increase in satisfaction after the procedure as comparable with a control
group of patients who will not have an interaction with the newly designed leaflet on
upper gastrointestinal endoscopy. If leaflet and client make transactions goals will be
obtained. If goals are obtained satisfaction will occur. If goal are obtained there is a good
nursing care. The goal outcome of leaflet interaction may or may not be influenced by the
age, sex, education, occupation, and previous experience with endoscopy and inpatient or
outpatient status.
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4. REVIEW OF LITERATURE
“Knowledge is of two kinds: we know a subject ourselves or we now where we can
find information upon it.”
(Samuel Johnson, April 18, 1775)
Introduction
The term literature review refers to the activities involved in identifying and
searching for information on a topic and developing and understanding of the state of
knowledge on that topic. Literature reviews can serve a number of important functions in
the research process. A systematic review aims to discover research ideas, what is
unknown about the research topic, conceptual framework into which a research problem
will fit and information on the research approach41.
The studies reviewed for the present study is organized under the following
headings:
1) Diagnostic upper gastrointestinal endoscopy
2) Benefits of information giving
3) Benefits of increasing awareness in patients
4) The design of patient information materials
5) Literacy and education in India
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6) Growth of interest in patient satisfaction
7) Dimensions of satisfaction
8) Psychological aspects of care
9) Satisfaction as an outcome measure
10) Effectiveness and outcome research
11) Conclusion
1. Diagnostic upper gastrointestinal endoscopy
The method of diagnosis and treatment of digestive diseases known as
gastrointestinal endoscopy has existed for about 120 years. Although the first gastroscope
dates to about 1968, our present, presumably modern, era of digestive endoscopy began
in 1957 with the advent of the fiberoptic endoscope42. In little more than 40 years
gastrointestinal endoscopy has profoundly altered and fundamentally improved the care
of patients with gastrointestinal diseases. Fiberoptic endoscopy is one of the most
clinically helpful and rapidly developing forms of medical investigation. The purpose of
the Endoscopy centers is to care for patients who require an endoscopic procedure in an
environment that provides an appropriate level of nursing and medical care supervision.
Upper gastrointestinal endoscopy can be a very challenging procedure, even in the hands
of the most experienced endoscopists. It is essential to have a complete understanding of
instruments, their operation, indications, contraindications, preparation, potential hazards,
complications and appropriate technique to maintain patient safety43.
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Definition
Upper gastrointestinal endoscopy involves the use of a flexible tube to examine
the upper intestinal tract including the esophagus, stomach and duodenum. The doctors
can also take tiny biopsies during the test, which a later be analyzed in the laboratory.
This is done painlessly using an endoscope44, 45.
Endoscope
An endoscope is a flexible fiberoptic scope with a light that helps a physician to
see inside certain internal organs. When the scope is inserted through the mouth, the
lining of the esophagus stomach and upper duodenum can be visually examined for any
abnormalities or growths a biopsy can be taken through the endoscope of any suspicious
areas that are seen46, 47.
How endoscopy works?
The endoscope is composed of extremely thin threads of bendable glass which
transmit light and images back to the viewer. The doctor can therefore see the structures
of the upper gastrointestinal tract directly by looking through the endoscope and make a
diagnosis. By inserting instruments, the doctor can also take specimens or remove foreign
objects or polyps48.
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Indications
Upper gastrointestinal endoscopy is often useful in finding and treating problems
such as49, 50:
• Abdominal pain
• Fullness of the stomach
• Anorexia
• Weight loss
• Esophageal reflex symptoms
• Upper abdominal distress, which persists despite an appropriate trial of therapy
• Bleeding from the digestive tract
• Cancers of the stomach or esophagus
• Chronic heartburn and indigestion
• Diagnosis and removal of stomach polyps
• Dilatation of esophageal strictures
• Gastritis or stomach inflammation
• Hiatus hernia
• Removal of swallowed objects
• Trouble in swallowing
• Treatment of the ‘ulcer bacteria’
• Ulcers of the stomach and duodenum
• Unexplained chest pain.
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Contraindications51, 52
• Uncooperative or confused patient
• Unable to obtain informed consent (emergency exceptions exist)
• Lack of necessary nursing /technical support and /or endoscope equipment
• Patient ate food or antacids (or had enteral feeding) within 4 hours of procedure
• Unstable cardiac patient
• Gross coagulopathy
• Patient with massive upper gastrointestinal bleeding
• High-grade intestinal obstruction
Problems53
• Agitation of patients
• Over sedation
• Getting lost (unsure of location)
• Encountering resistance
Complications 46, 47, 48
• Bleeding
• Perforation
• Death
Preparing patients for upper gastrointestinal endoscopy54-60
Review: During the initial clinic visit, the endoscopists should review all aspects
of a patient’s case or endoscopy nurses. They include history and symptom analysis,
review of radiological contrast studies and routine laboratory values.
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Explanation: A full explanation of the procedure and what the patient can expect
will greatly aid the endoscopist, since many fears or misconceptions can be eliminated in
anxious patients. Many endoscopy centers will also give patients an information
pamphlet or instruction document that will also answer questions.
Patient’s cooperation: The patient’s cooperation is essential for a successful
examination. There are things that patient a can do before the test to help.
Preparation: The examiner will want the patient’s stomach empty during the
procedure so that the doctor’s vision is not blocked by particles of food. If the test is
scheduled in the morning the patient must not eat or drink any thing after 10 PM the night
before the test. The patient must gargle and brush your teeth in the morning.
Medications: The patient must not take the medications that his/her personal
physician has prescribed in the morning of the test. But he/she must bring along those
medications when coming for the test, so that he/she can have it after an hour of the
resting period. If the patient is a diabetic, he/she must inform the physician in advance.
Informed consent: An informed consent is to be signed by the patient or his/her
representative prior to the procedure indicating that he/she has received the appropriate
and necessary information regarding the examination including its benefits and potential
risks and agrees to undergo the evaluation.
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The test: Normally the patient will be asked to lie on his/her left side on an
examining table. The patient’s head will be on the pillow and should be comfortable and
looking straight ahead with chin tucked in. The examiner will sit or stand before the
patient; a mouthpiece with an aperture wide enough to permit passage of the endoscope is
placed in between the teeth. The endoscope is then passed through the mouthpiece and
gently passed through the mouth examining each and every part of upper digestive tract.
The procedure is complete within 10-15 minutes. The discomfort appears once the tube is
removed.
Post procedure management: After the procedure is completed patients should be
observed for a minimum of one hour. It is normal to have a sore throat for a while after
the test, but it is important to report any new chest or abdominal pain promptly to the
doctor. The patient should not drink or eat for one hour after the test. The patient may
take his/her normal solid diet and the medications once the numbness is completely off.
The typed copy of the result is given in about 15 minutes.
2. Benefits of information giving.
Early and recent research has established that giving information to patients in
hospital prior to surgery decreases pain and stress associated with surgery and reduces the
anxiety levels of patients undergoing diagnostic tests. Giving appropriate information to
patients can improve the quality of care provided in a variety of clinical settings61. A
quasi-experimental study in California examined the effects of information about an
impending threatening event on subjects’ expectations and the intensity of their
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emotional response to the event. Examination of the relationship between type of
information and anxiety suggests that procedural and sensation information differentially
affect anxiety. Some previous investigations on structured and unstructured teaching
prior to surgery and invasive procedures also indicated that the effectiveness of structured
teaching fell into two categories: physiological and psychological62, 63.
A sense of control plays an important role in decreasing patient’s stressful
reactions to invasive medical procedures. A research16 on patient’s control and the
information imperative in Maryland demonstrated that providing patients with procedural
and sensory information enhances cognitive control, while facilitating active participation
in the procedures increases behavioral control. The patients’ perceptions of what they
need to learn are important determinants of learning outcomes. The adult learner is a
person who is motivated by the immediate needs of the situation and the self-directed
need to learn.
Patient’s right to information.
The London government in the 1997 under Department of Health (DOH)
acknowledged the importance of patient’s right to information. The Government’s White
Paper “Working for Patients” in the year 1989 emphasized the necessity to put the needs
of the patient first. With regard to information giving it proposed that patients should be
provided with clear information about what was to happen to them and rapid notification
of results of tests64. The importance of giving information to patients in a hospital has
been further accentuated by the introduction of ‘Patients’ Charter’. It states that a patient
has a right to be given clear information about any aspect of treatment or care received.
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Reinforcing the significance of informing patients, the government in 1996 prepared
‘Guidelines for professional practice document’. It notes that: If a patient or client feels
that the information they received was insufficient, they could make a complaint to take
legal action31. American Hospital Association’s Patient’s Bill of Rights emphasize that a
patient has the right to obtain from his physician complete, current information
concerning his diagnosis, treatment and prognosis in terms the patient can be reasonably
expected to understand. So there is a need to put needs of the patient first. Patients should
be provided with clear information about what was to happen to them. In order to comply
with the patient’s right; health professional should consider whether they get their
message across to patients. Patients are essential source of data and patients have a right
to have their view taken into account when planning and evaluating services65.
Analysis of “an informed consent”
Definition of consent
A definition of consent was provide by Gillon (1986) as “a voluntary and
uncoerced decision made by sufficiently competent or autonomous person on the basis of
adequate information and deliberation to accept or reject some proposed course of action
that will affect him or her.”65 Kendrick in 1994 linked autonomy with consent: There is a
close relationship between autonomy and informed consent: the former being concerned
with freedom and choice, the latter being the key which unlocks and enables their
expression. Beauchamp and Childress in 1983 provided a clear definition as “the
autonomous person determines his or her course of action in accordance with a plan
chosen by him or herself”65. When searching the literature in relation to consent, in
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general, the main areas that seemed to keep coming up were the age of consent, consent
to treatment and parental consent and that words generally associated with consent are
competence, information or informed consent and implied consent66.
Informed consent
Consent allied to the term informed means that patients should be given the
amount of information needed to make an informed choice about a given treatment or
intervention67. According to English law, for a valid consent to be obtained, the doctor
must give the patient sufficient information to enable them to understand the nature and
consequences of the proposed treatment64. The court recognizes that a doctor may decide
what is in the patients best interest to known provided any decision to withhold
information was reasonably made. In terms of ‘filling in’ with current literature on
consent in practice, certainly indicate that informed consent is high on the agenda as an
integral part of patent’s rights65.
The process of obtaining informed consent can be summarized with the acronym
EMBRACE.54
E xplanation of the recommended procedure.
M otive or reasoning behind the medical recommendations.
B enefits.
R isks
A lternatives.
C omplications
Side E ffects.
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Implication of “informed consent” for nursing
Despite the familiarity of the term ‘informed consent’, from the available
literature there is an impression that the giving of consent for an intervention is generally
regarded as part of the role of the medical practitioner. However, the investigator found a
wealth of literature in the nursing journals66 about the issues of consent; patient has the
right to receive personal health information necessary to give informed consent prior to
the start of any procedure and/or treatment. There is a danger in nursing to sideline the
concept of consent as a concept affecting doctors’ only. It has been specifically
mentioned in the late 1990 by Department of Health of England, providing guidelines to
members of the healthcare profession on gaining consent from patients for treatment67.
As nurses, we encounter situations every day, which challenge our skills of
communication: trying to arrange how much information a patient needs to make an
informed consent30, 31
In a study68 to determine the level of knowledge achieved by patients who have
read a simple information sheet on gastroscopy and flexible sigmoidoscopy, the majority
of patients (98%) felt that patients should be formally tested as to whether they
understood what they are told in the consent process. The conclusion of the study was:
consent needs to be supported by easy-to-read information and the patient’s
understanding needs to be formally tested. Important concepts must be included in this
information as well as any uncommon risks of the procedure. In order to ensure that the
information can be understood the text should be reviewed by an experienced
educationalist69.
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3. Benefits of increasing awareness in patients
The benefit of increasing awareness through information giving prior to surgery
and diagnostic tests is well documented.5, 6, 7. Patient’s stress and anxiety have an impact
on their tolerance for endoscopic procedures. Researchers suggest that fear is a normal
reaction to stress. Stress may be defined as an uneasiness that is related to a situation
where danger is anticipated. An understanding and an awareness of stress in patients will
enable nurses to care for them in an effective manner7. Some studies63, 66 of psychological
preparation have shown significant benefits on a variety of measures of stress. Some
studies35’70 suggested that the effect of information varies according to the individual’s
coping mechanisms and that most adults respond to stress through information seeking
coping mechanisms. Studies have showed that preparing the patient psychologically can
significantly reduce the stress of surgery and diagnostic tests and hospitalization. Some
research demonstrated that giving relevant preoperative information to patients decrease
the pain and stress they experience postoperatively65.
Stress is now generally regarded as an interactive process in which factors in the
environment and in an individual combine to produce stress. Central to the experience of
psychological stress is the process of cognitive appraisal, which involves consistently
examining situations and deciding their implication for well being71. Seeking information
about an event is a significant mode of coping. It enables a person to modify, avoid or
minimize the impact of a situation, thereby reducing the degree to which it is appraised as
stressful. This proposition has been tested in a large number of studies with regard
supplying information prior to medical and surgical procedures72. Some studies have
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examined cognitive coping strategies and information about sensory and procedural
information lessens anxiety and is associated with shorter recovery72. Some other studies
have demonstrated that preoperative program designed to psychologically and
emotionally prepare the child for admission and surgery help reduce the severity of
anxiety and subsequent behaviors73.
Patient’s view about information giving
There is evidence to indicate that patients view communication as an issue that is
central to their care. Studies30, 31 have investigated patient’s attitude to seeking sensory
and procedural information and identified wide spread dissatisfaction by patients with
regard to transmission of information from patient to doctor and from doctor to patients.
The patient’s preferences for type of information, its timing and format of preparation
were examined and over 90% patients approved this type of preparation. Most preferred
type of information was a booklet containing a composite of sensory, procedural and
reassuring information as well general information about admission procedures71-73. The
study emphasized the patient’s consistency preference for information in advance of
hospitalization and for receiving preparatory information. A descriptive study70 examined
patient education needs as reported by congestive heart patients and their nurses. Patients
rated information as more important than nurses rated the same information areas.
Written information
Patients need and want written information. There is evidence that giving
comprehensible information increases overall satisfaction with the care given by
healthcare professional66. Written information is a cost effective intervention that
complements verbal advice given by healthcare professionals. Information from a variety
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of sources they sought even more and felt that information in written form was useful and
appropriate27. Indeed, most health professionals recognize the need for written
information and literature exists giving guidelines on how to produce this resource. Some
of the studies31, 32
, which have evaluated written information, have looked at recall
behavioral changes and patient satisfaction.
4. Information leaflet as a method of providing information.
A leaflet is printed sheet with information package74. A survey75 was conducted to
evaluate effectiveness of an information leaflet for patients undergoing colonoscopy. The
result of survey suggests that the leaflet has been instrumental in client learning about the
procedure, as shown by the high positive satisfaction response provided to the
questionnaire. A British study evaluated73 preoperative information booklet dealing with
aspects of ICU. All respondents rated the booklet ‘very worthwhile.’Chumbley, Hall and
Salmon conducted a study69 in 2002 to formulate and evaluate an information leaflet for
patients using patient-controlled analgesia incorporating information thought to be
important by patients. Patients’ contribution led to a major change, producing a leaflet,
which was clearer, more attractive, and more informative and which proved more
satisfactory to patients. A descriptive study74 of the readability of patient information
leaflets designed by nurses examined the readability of nurse–designed written
information leaflets.
Design of a patient information material
Although medical and nursing journals provide some guidance, many healthcare
professionals are unaware of the magnitude of the illiteracy problem in this country. An
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indeed conservative estimate of America suggests that one in five adults lack the reading
and writing ability to handle the minimum demands of daily living74This problem is
especially critical among the poor, women and elderly31. Therefore, the information must
be complete, detailed and personalized according to the culture and learning capacity.
Leaflet information will facilitate communication of complete, concise a clinically
pertinent instructions75. Written patient information materials can be valuable
communication tools for teaching and reinforcing the verbal message, especially in the
present climate of today’s health services where patients are in hospital for such short
times. They are only useful if the patient is able to read and understand them, otherwise
they become an expensive waste of resources76.
5. Role of literacy and education in designing patient information material
As a designer of new set of information materials a nurse should consider the
literacy rate of country74The national average of literacy rate of India is misleading as
wide variations exist between the states. Although the literacy rate has improved since
1991 census but there is a clear differences between literacy rates4among males and
females. It was decided in 1991 census to use the term literacy rate for the population
relating to seven years age and above. A person is deemed as literate if he or she can
read and write with understanding in any one language. A person who can merely read
but cannot write is not considered literate. The national percentage of literates in the
population above 7 years of age is about 54%. The literacy rates of Karnataka according
to the census of 2001: male- 76%, female- 56%, and total- 67%; Tamil Nadu: male-
82%, female-65% and total- 73%; Andhra Pradesh: male- 71%, female- 51% and total-
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61%; Kerala: male- 94%, female- 88% and total- 91%. On the other hand Bihar and
Jharkhand had a literacy rate of only 49%. The states which have literacy rates below
the national average are Arunachal Pradesh- 58%, Andhra Pradesh- 61%, Rajasthan-
61%, Bihar- 49%, Jammu and Kashmir and Uttar Pradesh- 58%, Madhya Pradesh- 64%
and Orissa- 64%1-4.
Guidelines for nurses to design patient information materials
Long sentences, medical terms and small print make hospital information
brochures and consent forms difficult for many patients to understand74, 75.
There are,
however, things nurses can do to make written information for patients more accessible.
1) Use clear titles, headings, and subheadings to summarize main points.
2) Emphasize important information in bold type.
3) Highlight important information in bold type.
4) Highlight important points with questions or a box format.
5) Use a list format whenever appropriate and possible.
6) Print martial in an 8 or 10-point type size.
7) Test material on a random sample of patients for feed back.
8) Use large, bold-face print to accommodate patients with special needs such as
diabetic or cataract patients.
6. Information giving and upper gastrointestinal endoscopy
Providing the patient with information is an important part of the preparation for
an endoscopic procedure30. In most setting, the information includes written material that
is given to the patient before the procedure. This typically includes a description of the
actual procedure, its usefulness and risks, and the relevant preparation on the patient’s
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part31. Nursing literature supports the suggestion that endoscopy nurses use a
combination of methods to achieve psychological preparation for procedures according to
the patient’s ability to cope. Some previous researches have shown that information
giving relieves anxiety and is considered an act of reassurance76. Endoscopy nurses can
help to relieve such anxieties, using their skills to deep the patient safe and comfortable
and explaining the coming procedure in terms the patient can understand. Most
endoscopy nurses are practiced in teaching, reassuring and establishing a rapport with
anxious patients. However, a greater understanding of the psychological theories relating
to stress may enable endoscopy nurses to empower their patient, thereby reducing fear
and anxiety, and providing holistic care during endoscopic procedures68. Clement and
Melby30 determined the amount and type of information given to patients before, during
and after undergoing gastroscopy investigations. There were statistically significant
differences between the information acquired by younger and older patients prior to the
procedure. Nurses appear to be the most important source of information for older
patients while the information leaflet was perceived as the most important source of
information for younger patients31. Thompson et al investigated the information provided
to patients undergoing gastroscopy procedures in Northern Ireland. Patients received
most of the procedural information from nurses, and they recognized the importance of
providing sensory information. Patients were generally satisfied with the information
provided32,77.
7. The growth of interest in patient satisfaction
At present, there is an increased emphasis on integrated care delivery and the need
to access information across the care continuum77. The delivery of medical care is
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changing dramatically. Patients are becoming customers, whereas physicians and nurses
are being viewed merely as providers78. To address these concerns, healthcare providers
must measure patient’s outcomes. The field of outcomes research has emerged to provide
tools to identify the most effective and efficient service. According to the Institute of
Medicine, quality represents “degree to which heath services for individuals and
populations increase the likelihood of desired health outcomes and are consistent with
current professional knowledge”. Quality comprises of two dimensions: the
appropriateness of service provided and the skills with which the appropriate care is
performed. In more simplistic terms quality can be defined as “doing the right things
right”. Patient satisfaction is a reflection of how the patient perceives an episode of care.
Patient satisfaction is vital to healthcare organization, as customer satisfaction to other
businesses. Patient satisfaction has become increasingly important in today’s healthcare.
Satisfaction may affect whether a person seeks medical help and /or complies with the
prescribed treatment79.
8. Dimensions of satisfaction
The first issue concerns the healthcare attributes, representing patient expectations,
which can be measured as the dimensions of satisfaction. In a meta-analysis79 of 221
satisfaction literatures, it was found that the attributes commonly used to measure patient
satisfaction were ranked in the order of importance: overall quality, humanness, technical
competence, outcome, facilities, and continuity of care, Access, and attention to
psychosocial problems81. A study82 in 1994 found that satisfaction was related to
patient’s perceptions of the quality of care. A descriptive, correlation study examined
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relationships between individual patient and nurse characteristics and patient satisfaction
with triage nursing care, patient satisfaction with triage nurse and patient’s intention to
return to a specific emergency department. Patient satisfaction nursing attribute reported
in this study are:-82
¾ Skillfulness in performing duties
¾ Knowledge of illness/problems
¾ Knowledge of patient specific problems
¾ Explanation of procedures
¾ Explanation giving in lay language
¾ Demonstrated interest
¾ Demonstrated genuine concern
¾ Demonstrated gentleness in procedures
¾ Receptiveness to patient questions
A descriptive correlation study83 examined the satisfaction levels of urgent
patients in relation to nursing care, the emergency department environment, auxiliary
services and information received. The components of nursing care in patient satisfaction
questionnaire are:-
¾ Overall caring and compassion
¾ Effort to understand patent’s problem
¾ Concern for patient’s privacy
¾ Recognition of individual qualities and needs of patient
¾ Knowledge of problem and care
¾ Watchfulness of patient condition
¾ Ease of attaining nurse attention when needed
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Some studies84, 85 identified three factors that influence the consumer’s satisfaction with
nursing care: nursing personality characteristics (sensitivity, friendliness, social courtesy,
helpfulness and kindness), nurse caring behaviors (empathy, compassion,
communication, and comfort measures), and nursing proficiency (knowledge, technical
proficiency, and organizational skills)84.
9. Psychological aspects of care
The impact of perceived effective nursing care on the level of patient’s
satisfaction in the emergency department was examined and the study concluded that
there was a tendency for staff to concentrate on technical competence rather than on
psychosocial care, as measured by satisfaction ratings85. Psychosocial aspects of nursing
care were found to be the highest satisfying aspects of patients in a study conducted. The
psychosocial aspects included the way the care providers showed concern and
compassion, the patience of the nurse who cared of the patient, and the encouragement by
the nurses about how the family could help the patient. Along with psychosocial aspects,
the patient’s perception about the nurse’s affective behaviors was reflected in satisfaction
with nursing care. Affective behaviors were examined in a group of inpatients on a
medical surgical unit. The important behaviors were: interpersonal skills, friendliness,
and helpfulness.
Technical competence: While several studies discuss the importance of
psychosocial aspects, one study found that technical quality of care was more important
than perceived timeliness of care or bedside manner in determining patient satisfaction.
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Communication: Studies showed that patients wanted simple, easily understood
information presented in a timely fashion. Patient satisfaction is closely related with the
patient’s intentions to return to a department. Perceptions about waiting times, both actual
and perceived, and information given were found to affect satisfaction81.
Consumer’s perception of quality of care: An important area of current research
focuses on providing quality information to consumers. Despite extensive research on
defining and measuring healthcare quality, less attention has been given to consumer’s
perceptions of quality healthcare. Most studies examined the type of information valuable
in choosing among varied health plans. The provider’s perceptions of quality are different
form patient’s perceptions. In a study on consumer’s description of quality of healthcare
as having access to care, competent and skilled providers, proper treatment, freedom to
choose physician and hospitals, providers who communicate effectively, providing who
teach about conditions and treatments, providers who are caring and concerned, being
treated with respect, providers who act professionally, getting better81.
Quality nursing care means nurses who are competent and skilled, nurses who
communicate effectively with patients, being taught about conditions, treatments,
mediations and self care, nurses who treat patients with respect, getting the proper
treatment and care84. Also important to consumers in their definitions of quality care are
providers and staff who communicate with them, listen and talk to them in
understandable terms, are responsive to their needs, and treat patients with respect and
the interpersonal relationship of physicians, nurses and other providers with patients.
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10. Satisfaction as an outcome measure
Client satisfaction is of fundamental importance as a measure of the quality of
care because it ices importance as a measure of the quality of care78. The measurement of
satisfaction is, therefore, an important tool for research, administration and planning.
During the last decade measuring patient satisfaction has come to be regarded as the
method of choice for obtaining patient’s views about their care72. The patients are an
essential source of data about how the service functions; and those patients have a right to
have their views taken into account when planning and evaluating an episode of care. The
main method for measuring satisfaction is the self-completion questionnaire, which
delivers information in a form, which can be used for comparison and monitoring. The
emphasis on patient satisfaction is consistent with the trend toward holding health
professional accountable to their consumers. The Griffiths report of 1988 by Department
of Health and Social Security identified for health service providers to elicit patient’s
views about their expectations and experiences of care81.
Sensitivity to user’s values
Another reason for the interest in patient satisfaction has arisen from the need to
evaluate health practices using outcomes, which are sensitive to user’s values. Previously,
trials of new forms of care have used clinical outcomes determined by knowledge rather
tan patient acceptability. Satisfaction, on the other hand, is a patient-focused outcome that
can be used to evaluate the effectiveness of nursing care. Patient satisfaction has been
used to evaluate gastroscopy procedure, colonoscopy procedure, endoscopy unit
performance, emergency nursing are, patient education programme, patient controlled
analgesia, video information, triage nursing care, pre-operative information, information
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leaflet designed by nurses, community mental health programme, nurse-patient
relationship, written health information, nursing home care quality, quality in
gastroenterology, procedure specific outcome, quality assurance in endoscopy unit, and
nursing care behaviors. A further reason for the interest in measuring satisfaction draws
from the belief that patient satisfaction is an integral part of high quality care and any
system of delivering nursing care must pass this test. Patient satisfaction is a necessary
condition for effective care’85
11. Effectiveness and outcome research
According to Polit and Hungler, outcome research, designed to document
effectiveness of healthcare services, is gaining momentum as a research enterprise in
nursing and healthcare fields. Outcome research can be defined as the systematic study of
clinical practice with special attention to patient-centered outcomes41. Its emphasis is on
effectiveness rather than efficacy. Efficacy represents the benefits a medial or nursing
intervention. Effectiveness represents the outcome of an intervention in the real world,
using a heterogeneous group of patients from varying clinical contexts. Effectiveness
answers the question of whether an intervention can work in routine practice. Deficiency
determines whether it is worth doing. Outcome research is now being called effectiveness
trials82. Effectiveness trials strive to include a wide variety of practice settings to increase
the generalizability of their results. Effectiveness trials also collect data regarding quality
of life, functional status, and effectiveness of interventions86. According to the concept of
management by objectives, the key result areas of an effectiveness trial can be expressed
in quantitative as well as qualitative terms. Quantitative means the number and cost of
trial and qualitative terms related to the effectiveness of treatment and patient’s
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satisfaction. Outcome research approach contributes to the objectives of the whole rather
than a part87.
12. Conclusion
From the above literature review the investigator is convinced that client teaching
and information on medical procedures is recognized as one of the important task for the
nurse. All the above studies point out that patients information needs to any invasive
procedure is essential for better compliance. Above all the information must be complete,
concise, standardized and presented according to the client culture and learning capacity.
Several studies have suggested that patients do not recognize what they expected from
health services until an episode of care is completed. The key result areas of leaflet
information in this study are awareness and satisfaction.
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4. METHODOLOGY
The research methodology is the framework for conducting study. This chapter
deals with the description of the methods and different steps used for getting and
organizing data. It includes description of research approach, research design, setting,
sample, sampling technique, development and description of tools, development of leaflet
information, pilot study, data collection, plan for data analysis and ethical considerations.
RESEARCH APPROACH
In view of the problem and to accomplish the objectives of the study an outcome
research approach was considered to be most appropriate for this study. Outcome
research helps define best practice, in a real-time setting. Outcome research develops a
systematic process to collect, quantify and objectively verify performance. Outcome
research provides a method to assess the relative effectiveness of an alternative
intervention.
In this study, the investigator systematically studied the cognitive and perceptual
success of a newly designed leaflet on upper gastrointestinal endoscopy with special
attention to patient centered data. A key emphasis was the effectiveness of leaflet
information in terms of awareness and patient satisfaction. Effectiveness is the utility of
intervention (leaflet information) in the real world (endoscopy unit) that is, behavior of
patients and healthcare providers regardless of their training and area of practice.
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FIGURE -2 SCHEMATIC REPRESENTATION OF RESEARCH DESIGN
DATA
POPULATION SAMPLE TOOLS VARIABLES COLLECTION OUTCOME
Independent
All All variable EXPERIMENTAL EXP
consecutive patients Information Leaflet
patients who met Leaflet information * Leaflet 2nd posttest-1 Leaflet
scheduled for inclusion 1st information day Endoscopy information
UGIE at & PostTest-1 day * Verbal PostTest-2 enhanced
SJMCH from exclusion Dependant information awareness
21/02/05 criteria. PostTest-2 variables CON on upper
to Awareness 2nd GI
31/03/05 Satisfaction CONTROL day PostTest-1 Endoscopy &
1st Endoscopy patient
day * Verbal PostTest-1 satisfaction
information
UGIE – UPPER GASTROINTESTINAL ENDOSCOPY EXP – EXPERIMENTAL CON – CONTROL
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RESEARCH DESIGN (FIGURE-2)
This study attempted to assess the effectiveness of information leaflet on
upper gastrointestinal endoscopy, by ascertaining its impact on the awareness of
patients measured by a structured patient instrument. The study was conducted also to
find out the correlation between the written information and the satisfaction with the
actual procedure at the endoscopy unit as perceived by the patient subjects.
The research design used for this study was a randomized, controlled, post test
only experimental design. It was selected since it aided in attaining the study
objectives. The post test only design was preferred to exclude the effect of pretest on
the post test awareness.
VARIABLES UNDER STUDY
Independent variable
¾ A newly designed information leaflet on upper gastrointestinal endoscopy
Dependent variables
¾ Awareness of patients regarding upper gastrointestinal endoscopy.
¾ Satisfaction with the actual endoscopy procedure as perceived by the patients.
Attributable variables (Baseline)
¾ Age, gender, education, occupation, previous experience of upper
gastrointestinal endoscopy, outpatients, and inpatients.
SETTING OF THE STUDY (FIGURE-3)
The settings of this study were the endoscopy unit (OP Room No.28) where
the appointment and endoscopy procedure takes place and the inpatient departments
of SJMCH from where the patients were referred for diagnostic upper gastrointestinal
endoscopy procedure.
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STORE WORK AREA CONFERENCE TOILET NURSES’
ROOM ENDOSCOPY ROOM LOUNGE
ROOM - 2
TOILET
DOCTOR’S
ENDOSCOPY ROOM
TOILET RECOVERY
ROOM
ENDOSCOPY ENDOSCOPY DOCTOR’S
COUNTER ROOM – 2 ROOM
WAITING ROOM
ANAESTHESIA CLINIC DAY CARE WARD
FLOW OF PATIENT’S MOVEMENT POSITION OF THE INESTIGATOR
FIGURE -3 FLOOR PLAN OF GASTROINTESTINAL ENDOSCOPY UNIT
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The study site was under the Gastroenterology department of SJMCH. As per
the annual statistics of patients of this department in the years 2003-2004, the
department had an average inpatients of 1141, outpatients of 10196, cross
consultation of 1133, average bed occupancy of 72%, average/day OPD attendance of
41, and average hospital stay of 5.5 days and inpatient consultation of 1400 patients.
The annual statistics of procedures of endoscopy unit in the years 2003-2004
showed 3851 routine upper gastrointestinal endoscopies, 428 emergency upper
gastrointestinal endoscopies, 740 routine colonoscopies, 82 emergency colonoscopies,
243 sigmoidoscopies and 140 ERCPs.
POPULATION
The population for this study was all OP and IP consecutive patients scheduled
for diagnostic upper gastrointestinal endoscopy at SJMCH from 21.02.05 to 31.03.05.
SAMPLE SIZE
To estimate the sample size for a study using categorical data it is necessary to
know the effect size or odds ratio and the proportion of subjects expected for the
diagnostic upper gastrointestinal endoscopy. The investigator expecting a 20%
difference in the awareness and satisfaction of experimental subjects after the
administration of leaflet on upper gastrointestinal endoscopy recruited a sample size
of 200, with 100 subjects each in control and experimental groups.
INCLUSION CRITERIA FOR SAMPLING
Patients undergoing upper gastrointestinal endoscopy in SJMCH, if they
conformed to the following criteria, that is, they are:
1) Between 18 to 60 years of age.
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2) Mentally alert and able to communicate freely.
3) Undergoing their first upper gastrointestinal endoscopy or repeat endoscopy

not within 6 months.
4) Are willing to participate in the study.
EXCLUSION CRITERIA FOR SAMPLING
1) Patients posted for emergency upper gastrointestinal endoscopy.
2) Patients who are sedated or confused
3) Patients who will have the upper gastrointestinal endoscopy on the same day
of appointment.
4) Patients who had upper gastrointestinal endoscopy within the past 6 months.
SAMPLING TECHNIQUE (FIGURE-4)
The sampling frame consisted of all consecutive patients both IP and OP
scheduled for diagnostic upper gastrointestinal endoscopy and who fell within the
inclusion criteria. All potential patient subjects meeting the inclusion criteria were
invited to participate until the sample size of 200 was obtained. Each patient who met
the inclusion criteria was given an information package explaining the identification
of the investigator, the nature and purpose, benefits of the study and what is expected
of him/her during the study. Each patient who volunteered signed a consent form that
explained the purpose and benefits of the study.
The allocation sequence was generated by the random placement of 250
sealed, thoroughly shuffled and sequentially numbered envelopes by a person not
involved in the research study. The investigator opened the sealed, sequentially
numbered cover in which there was a folded printed paper written either as
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‘CONTROL’ or ‘EXPERIMENTAL’. The investigator was blinded until opening the
cover and this method was selected to reduce bias to the minimum. If the cover
indicated ‘control’ the outpatient subject obtained appointment form and verbal
explanation by the endoscopy counter clerical staff and if the cover indicated
‘experimental’ the outpatient subject obtained both appointment form, verbal
information by the endoscopy counter clerical staff and the newly designed leaflet
information on upper gastrointestinal endoscopy from the investigator. If the cover
indicated ‘control’ inpatient subject received verbal explanation by the night duty
nursing staff and if the cover indicated ‘experimental’ the inpatient subject was
offered the newly designed leaflet information on upper gastrointestinal endoscopy in
addition to the verbal explanation given by the night duty nursing staff.
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Experimental (100)
SAMPLES (200) Control (100)
250 covers were sealed, randomized & sequentially numbered
Total upper GI Endoscopy from 21.02.05 to 31.03.05 (400)
INCLUSION
EXCLUSION CRITERIA
CRITERIA
ELIGIBLE SUBJECTS 250
OBTAINED INFORMAL CONSENT ON DAILY BASIS
ALLOCATION SEQUENCE GENERATED BY THE

INDICATION IN THE RANDOMISED COVER
CONTROL GROUP EXPERIMENTAL GROUP

(NO LEAFLET) ,,(ADMINISTERED LEAFLET)
OUTPATIENTS INPATIENTS
APPOINTMENT FORM APPOINTMENT FORM
VERBAL EXPLANATION VERBAL EXPLANATION
ARRIVAL FOR ENDOSCOPY POST TEST – 1
POST TEST - 1 ARRIVAL FOR ENDOSCOPY
ENDOSCOPY ENDOSCOPY
POST TEST – 2 POST TEST – 2
FIGURE- 4: THE FLOW CHART OF SAMPLING TECHNIQUE
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*Review of Discussion with: * Personal
literature *Endoscopists experience
* Online *Endoscopy nursing team
PubMed & *Endoscopy office staff *Observations
Google search *Patients who had GI Endoscopy
FIRST DRAFT
DISCUSSIONS
Nursing team Endoscopist Guide Co-Guide Statistician
SECOND DRAFT
TRIALS WITH FEW PATIENTS
THIRD DRAFT
ESTABLISHMENT OF RELIABILITY
EXPERTS’ OPINION
SJCON Nursing Gastroenterologist Physician Surgeon HOD & Professor of

(2) service(1) (2) (2) (1) Medical surgical
nursing (4)
FOURTH DRAFT
TRANSLATED & EDITED IN KANNADA, TAMIL, TELUGU
PILOTED IN 20 PATIENTS
New leaflets Patient instrument
FIGURE-5: FLOW DIAGRAM OF LEAFLET and PATIENT INSTRUMENT-1
DEVELOPMENT
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LEAFLET AND PATIENT INSTRUMENT-1 DEVELOPMENT (FIGURE-5)
The investigator could not access instruments developed to assess the
effectiveness of an information leaflet on the awareness of patients undergoing upper
gastrointestinal endoscopy. Development of leaflet and patient instrument-1 began
with assessing patient’s perception of learning needs. Content typically included in
patient education for patients undergoing upper gastrointestinal endoscopy were
added from a review of literature, online PubMed and Google search, and discussions
with endoscopy team, personal observations and suggestions from endoscopists. The
subsequent content was submitted for review. The revised content was tried with few
patients and sent to experts for content validity. Items that the panel decided
unnecessary were deleted and additional items were included. Comments and
suggestions from experts regarding clarity, language, organization and simplicity
were also used to revise the wording of the items. The leaflet was piloted with 10
patients undergoing upper gastrointestinal endoscopy. The subjects were also asked to
add any additional items they believed were important to learn. There was no revision
requested during the pilot study presentation.
Leaflet design: (FIGURE-6). The leaflet dealt with four issues: the concept
of upper gastrointestinal endoscopy, the preparation before the procedure, the care
during the procedure and the care after the procedure. The leaflet is written in easy-to-
read English, comprising 560 words of which 70% were two syllables or fewer in
length. The sentences were 8-9 words long. The level of difficult words present in the
English version was made more understandable and simple while translated and
edited in Kannada, Tamil and Telugu. The final copy of the leaflet was designed with
improved illustrations on the cover page, easier language and a more legible lay out.
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FIGURE – 6: UPPER GASTROINTESTINAL ENDOSCOPY
CONTINUUM OF CARE
CONCEPT CARE CARE CARE

BEFORE DURING AFTER
SPRING MODEL OF LEAFLET INFORMATION

SOURCE: COURTESY OF SUMMA HEALTH SYSTEM. AKRORS. OTSIO
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The spring model outlined in figure shows the phases of upper
gastrointestinal endoscopy procedure which enhanced precision of information across
a continuum of care. The spring model stretched information to meet the needs of
patients from concept of upper gastrointestinal endoscopy, care before, during and
after the endoscopy procedure72.
Patient Instrument- 1 (Annexure –O)
A self report quantitative questionnaire was used to ensure the effectiveness of
leaflet information on the awareness of patients prior to undergoing upper
Cover page: An information package and informed consent (Annexure-G)
The cover page of patient instrument-1 consisted of an information package
which explained the identity of the investigator, the nature and purpose of the study,
the method of data collection, what is expected of before and during the study, the
benefits of the study, the number and sequence of data collection and an informed
consent to be signed by the patients if they volunteer for the study.
Section A: Baseline variables
Section A consisted of baseline variables like gender, age, education,
occupation, previous endoscopy, outpatients and inpatients.
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Section B: Opinion of leaflet information
Section B consisted of 8 items. Questions 1-7 were applicable only to
experimental group with a purpose of eliciting opinions on information leaflet prior to
undergoing upper gastrointestinal endoscopy. Item No.8 was a 5 point rating scale to
identify other sources of information from both subjects in experimental and control
groups
Section C: Awareness questionnaire
Section C contained 20 items/statements with 5 response options to assess the
awareness level of patients in both experimental and control groups. The items and
the right response option are based on the content of leaflet information. The
respondent had to tick against the box corresponding to the single best option .The
right answer has a value of ‘1’ and ‘0’ for the wrong answer. The total score is
computed by summing across all right items.
Patient Instrument – 2 (Annexure-S)
As a methodology to address the second objective of the study a post test-2 was
conducted after the endoscopy procedure. A literature search to locate instruments
measuring patient satisfaction after an endoscopy procedure was executed using the
online PubMed and Goggle and published journals related to Gastroenterology from
1995. To facilitate the collection of patient satisfaction data, an instrument developed
by Group Health Association of America (GHAA-9) published in Gastrointestinal
Endoscopy Clinics North America.1999; 9(4) were adapted for this study. The
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GHAA-9 questionnaire has been in existence for nearly 20 years and has been
validated in numerous patient populations. It is a quantitative structured self-report
questionnaire aimed to elicit from subjects their perception of actual performance of
endoscopy unit in relation to leaflet information on upper gastrointestinal endoscopy.
Response options are in the form of a 4 point scale namely, excellent, very good,
good, and fair. There were two items added by the investigator and responded only by
experimental group to determine the correlation between the written information
provided and the actual performance during and after the procedure as perceived by
the patient. The last two open-ended questions are included for the patients to write
down their own comments and suggestions. The post test-2 was translated and edited
in Kannada, Tamil and Telugu and piloted in 20 patients before the main study.
CONTENT VALIDITY
The content validity of the leaflet on upper gastrointestinal endoscopy and
patient instrument -1 was established by 10 experts: from the field of nursing (6),
general medicine- 1, general surgery- 1 and gastroenterologists – 2 (Annexure -D).
Comments and suggestions were invited (Annexure -E). Modifications were made on
the basis of suggestions and comments given by experts (Annexure -E). The leaflet
and tool were translated and edited in Kannada, Tamil and Telugu by language
experts (Annexure-G-V).
RELIABILITY
Reliability for the questionnaire was established using Test Retest method.
The questionnaire was admitted to 10 staff nurses once and then after 5 days again it
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was administered to same group. The scores obtained were utilized to check reliability
using deviation method. The value of r = 0.875. There is a positive high correlation.
The obtained value is greater than table value at 0.05 levels of significance.
THE PILOT STUDY
After obtaining a formal administrative approval a pilot study was conducted
on 20 patients from 17.1.05 to 25.1.05.The setting of the study were the endoscopy
unit (OP N. 28) and the inpatient departments of the SJMCH.
The purposes of the pilot study
• To determine the feasibility and effectiveness of instruments developed
• To determine the need for a change in the method of data collection
• To determine effectiveness of sample size and sampling technique
• To determine the feasibility of the study
The pilot study details
Outpatients were approached on daily basis to enroll in the research study, as
they came to take appointment for upper gastrointestinal endoscopy procedure about
one day or at least 12 hours before the procedure. Inpatients were recruited from all
departments over a period of one week. Patients were approached in the afternoon of
the previous day of procedure and sought consent to take part in the study. Before,
randomization the eligible patients were given a written information sheet in their
own language, explaining the purpose and requirement of the study. Informed consent
for the research study was taken in writing. Patients were randomly assigned to
control and experimental groups. The allocation sequence was generated by the
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random placement of thoroughly shuffled and sequentially numbered envelops by a
person not involved in the research study. The control group received verbal
information and an appointment form, which carries the time of procedure. The
experimental group, in addition to the above received a newly designed information
leaflet on upper gastrointestinal endoscopy.
Strength of pilot study
• Gained insight into the type of analysis to be used.
• Cleared about how to make a time plan for data collection.
• The research committee granted permission to conduct the main study.
Problems faced during pilot study
• Inpatients were not informed of the procedure
• Appointment form at times did not reach in ward in time.
• Majority of women population were illiterate.
• Patients of control group requested for leaflet information after the post test-1.
Modifications and suggestions
• If the subjects were not able to read or complete questionnaires due to

illiteracy, visual impairment or other physical problems, the caregivers could
be asked to read and explain the leaflet and instruments and to assist the
patient in completing the instruments.
• Delete the term ‘competency’ from item No.4 of patient instrument-2
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Stage Stage Stage Stage Stage
1 2 3 4 5
* Outpatients came to the
endoscopy unit to take
appointment * Study * Out patient E * Out patients
participants participants came for N completed post-
* Inpatients were identified had prescribed procedure D test 2 at the end of
from IP appointment register. minimum 12 O their resting time.
hours to * During their waiting S
* Identified study subjects read & time for the procedure C * Inpatients
were recruited based on the assimilate completed post test-1. O completed post –
exclusion and inclusion the leaflet P test 2 in the
criteria. information. * Inpatients completed Y afternoon of the
posttest 1 in their own procedure.
*Obtained informal Consent setting prior to coming P
for endoscopy. R
*Allocated subjects to exp & O
control groups with C
randomized cover. E
D
*Experimentals received: U
* Appointment form R
* Verbal explanation E
* New leaflet
* Controls received :
* Appointment form
* Verbal explanation
FIGURE – 7: DATA COLLECTION STAGES OF MAIN STUDY
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Details of main study (FIGURE-7).
Having formulated a new leaflet on upper gastrointestinal endoscopy, the main
study sought to ascertain whether it was effective in enhancing awareness of patients
before undergoing upper gastrointestinal endoscopy and increasing satisfaction of the
actual procedure as perceived by the patients in relation to the leaflet information
provided. A quantitative method of data collection and analysis were employed in this
study. Two self-completed patient instruments were employed and data was collected
before and after the endoscopy procedure.
The subjects were adult outpatients and inpatients having referred for
diagnostic upper gastrointestinal endoscopy from 21.02.05 to 31.05.05. Factors
controlled in this study were the inclusion and exclusion criteria set at the beginning.
Two hundred patients signed consent form on a daily basis. The subjects were
purposively selected and allocated to control and experimental groups by the random
placement of sealed, thoroughly shuffled, sequentially numbered covers by a person
who is not involved in this study.
Data collection procedure from outpatients
In order to have control over all the staged of this study the investigator
positioned herself in front of the endoscopy counter. Outpatients were recruited on the
day they came to take appointment for upper gastrointestinal endoscopy. The eligible
subjects were identified and the investigator offered information package to them.
After signing the informed consent by the subjects the investigator opened the sealed
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cover to allocate the subjects to the control or experimental groups. The subjects came
for endoscopy procedure on the day of appointment. The investigator offered them the
patient instrument-1 and completed the post test- 1 as they were waiting for the
procedure. The post test- 1 was picked up shortly before they were called for the
endoscopy procedure. Patients completed this questionnaire in about 15 minutes.
Then they went for the endoscopy procedure. At the end of resting period they were
offered patient instrument-2. Post tesst-2 was completed in about 10 minutes. The
investigator received back the instrument-2 as they were called to give the report of
their investigation.
Data collection procedure from inpatients
In the afternoon, all individuals scheduled for an upper gastrointestinal
endoscopy the following morning were identified from the patient appointment
register of gastrointestinal endoscopy unit. Each individual on the schedule was
identified by cross checking the patient record at nurse’s station to determine the age,
diagnosis, and purpose of the request for an upper gastrointestinal endoscopy. Then
each potential patient was met at his/her room/unit to ensure that the subject fall
within the inclusion criteria. After identifying the patient, the ward sister was notified
by the investigator that the patient was enrolled in the research study, but did not
reveal the method of study. Then the study continued as mentioned in the section of
outpatients. In the morning of the procedure the investigator offered patient
instrument-1 prior to coming to the endoscopy unit. Then they came for endoscope
procedure. The post test-2 was completed in the afternoon of the same day at their
room/unit.
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ETHICAL CONSIDERATIONS
Ethical approval to undertake this study was granted from institutional
research ethical committee and from the research committee of college of nursing.
The study site approval was obtained from the Director, Administrator, Nursing
Superintendent and the HOD of the gastroenterology department of SJMCH.
(Annexure-A).Cooperation was sought from all the endoscopists, doctors of the
inpatient departments, floor supervisors, the sister-in charges and other staff members
of the endoscopy unit and inpatient departments. An informed consent was sought
from patients to participate in the study after explaining the purpose, the method and
number of times the data will be collected from them. Ethical issues were considered
to ensure that no subject was disadvantaged in control group, received adequate
verbal information at the end of the completion of patient instrument-1 and the newly
designed leaflet on upper gastrointestinal endoscopy at the end of study if they desired
for it.
- 85 -
Figure – 8: DATA ANALYSIS PROCESS
250 COVERS WERE RANDOMISED
125 CONTROLS 125 EXPERIMENTALS
0 Declined to participate 1 Declined to participate
0 Unable to complete 2 Unable to complete

post test 1 post test 1
2 Unable to complete 1Unable to complete
post test 2 post test 2
0 Withdrew consent 0 Withdrew consent
2 Did not come for 3 Did not come for

endoscopy endoscopy
0 Did not return 1Did not return
instruments instruments
1 Postponed the 1 Postponed the
procedure after post test 1 procedure after post test 1
100 qualified for 100 qualified for
analysis analysis
ORGANIZATION OF THE DATA INTO A MASTERSHEET
GRAPH PREPARATION
COMPUTATION OF DESCRIPTIVE AND INFERENTIAL

STATISTICS
COMPARISON OF THE STUDY FINDING WITH THE PREVIOUS

STUDIES
- 86 -
TABLE- 1: DATA ANALYSIS PLAN
Objectives Statistics
• Distribution of subjects according to

Frequencies and percentages
the baseline variables
• To compare the baseline variables for

Chi-Square test
homogeneity.
• Objective-1 Mean, SD, SEM, 95% Confidence
Limit, Unpaired‘t’ test, Kolmogorov

To compare the awareness score of
and Smirnov test, Mann-Whitney
experimental and control groups
non-parametric test.
• Objective-2 Mean, SD, SEM, 95% Confidence
To compare the satisfaction score of Limit, Unpaired ‘t’ test, Paired‘t’
experimental and control groups test, Kolmogorov and Smirnov test,
Mann-Whitney non-parametric test.
Chi-Square test, Linear regression.
• Objective-3 ANOVA, Turkey Kramer Multiple
To determine the association between the Comparison test, Student‘t’ test.
awareness and baseline variables
- 87 -
5. RESULTS
This chapter deals with the analysis and interpretation of data collected to
assess the effectiveness of an information leaflet on upper gastrointestinal endoscopy
administered to patients undergoing diagnostic upper gastrointestinal endoscopy at
the endoscopy unit of SJMCH from 21.2.05 to 31.3.05. The quantitative and
qualitative information collected by a prospective case control trial using 200 samples
were reduced, summarized, organized, evaluated, interpreted and communicated in
this chapter.
The data are analyzed and organized as follows:
Section 1
Description of selected baseline variables of the study subjects.
Section 2
To compare of two groups’ variables for the homogeneity.
Section 3
Objective-1: To compare the awareness of patients in the control and
experimental groups before undergoing upper gastrointestinal endoscopy.
Section 4
Objective-2: To compare the satisfaction with the actual experience at the

endoscopy unit in the control and experimental groups after undergoing upper
Section 5
Objective-3: To determine the association between awareness and selected
baseline variables of both control and experimental groups.
- 89 -
Section -1: DESCRIBTION BASELINE VARIABLES
26% 25%
18-30years
31-40years
41-50years
51-60years
24% 25%
Experimental Group
FIGURE -9:
Percentage distributions of experimental group according to their age.
The experimental subjects were composed of more or less equal proportion in their
age distribution as shown in figure-9.
30% 24%
18-30years
31-40years
41-50years
51-60years
28% 18%
Control Group
FIGURE-10:
Percentage distributions of control subjects according to their age.

The figure10 shows that there were only 18% of control subjects between the ages of
31-40 years.
- 90 -
35%
Male
Female
65%
Experimental Group
FIGURE - 11:
Percentage distributions of experimental subjects according to their sex.
Figure 11 shows that among the experimental subjects 65% were males and 35%
were females.
27%
Male
Female
73%
Control group
FIGURE -12:
Percentage distributions of control subjects according to their sex.
Figure 12 shows that among the Control subjects 73% were males and 27% were
females.
- 91 -
P
28% 26%
30% 24% 24%
25%
18% 18%
20% 16% 14%
12% Experimental
15%
8% Control
10% 7%
5%
5%
0% 0%
0%
PR MS HS UG PG PRO OT
PR – Primary Education MS – Middle Secondary HS – Higher Secondary UG – Under Graduation

PG – Post Graduation PRO – Professional Training OT - Others
FIGURE- 13:
Percentage distributions of experimental and control groups according to their education.
Figure 13 shows that among the experimental subjects 72% had primary to higher secondary education as compared to 66% of control
subjects.
- 92 -
25%
19% 21%
20% 19% 19%
17%
15% 15%
15% 14% Experimental
12%
10% Control
10% 8% 10% 8%
7%
4%
5%
2%
0%
NIL LA HW RT PRO TECH BU OT
NIL – No Occupation LA – Laborer HW – House Wife RT – Retired

PRO – Professional TECH – Technicians BU – Business OT - Other
FIGURE-14:
Percentage distributions of experimental and control groups according to their occupation.
The figure 14 shows that 53% of experimental subjects were unemployed compared to 48% of control subjects.
- 93 -
26%
YES
NO
74%
Experimental Group
FIGURE-15:
Percentage distributions of experimental subjects according to their previous

endoscopy experience.
Figure 15 show that only 26% of the Experimental subjects had a previous
endoscopy experience.
33%
YES
NO
67%
Control Group
FIGURE -16:
Percentage distribution of control subjects according to their previous endoscopy
experience.
Figure 16 show that only 33% of the Control subjects had a previous endoscopy
experience.
- 94 -
50% 50% IP
OP
Experimental Group
FIGURE-17:
Percentage distribution of inpatients and outpatients in experimental Group.
Figure 17 shows that among the experimental group of study subjects 50% were
inpatients and 50% were outpatients.
40%
OP
IP
60%
Control Group
FIGURE-18:
Percentage distribution of inpatients and outpatients in control group.
Figure 18 shows that among the control group of study subjects 40% were inpatients and
60% were outpatients.
- 95 -
Section -2
TABLE-2: COMPARISON OF TWO GROUP’S VARIABLES FOR HOMOGENITY
Baseline Categories Experimental Control Chi-Square test

variables n=100 n=100
f
f
Age 18-30 Years 25 24
31-40 Years 25 18 X2 = 1.75df(3 )NS
41-50 Years 24 28
51-60 Years 26 30
Sex
Male 65 73 X2 = 1.14df(1) NS
Female 35 27
Education Primary 18 24
Middle Secondary 28 24 X2 = 507df(5) NS
Higher Secondary 26 18
Undergraduates 16 14
Post Graduates 5 12
Professional 7 8
Any other 0 0
Occupation NIL 15 19 X2 = 8.6df(7) NS

Laborer 19 21
House wife 19 8
Retired 4 2
Professional 10 17
Technician 15 12
Business 10 14
Others 8 7
Previous Yes 26 33 X2 = 0.86df(1) NS

endoscopy No 74 67
OP 50 60 X2 = 4df(1) NS
Admission IP 50 40
Kannada 38 43 X2 = 1.1df(1) NS
Language Tamil 25 25
Telugu 10 11
English 27 21
NS: Not significant at 0.05 percent level

The above table agrees that the selected baseline parameters of the experimental and
control groups were comparable. The difference between the two groups were not statistically
significant at 5 percent level (P>0.05).
- 96 -
Section -3
AWAERENESS IN CONTROL AND EXPERIMENTAL SUBJECTS
Objective-1:
To compare the awareness of the patients in the control and experimental groups before
undergoing upper gastro intestinal endoscopy
TABLE -3:
Comparison of awareness of subjects on upper gastrointestinal endoscopy after the

leaflet intervention measured before undergoing the procedure.
Parameters Experimental Control Mean Unpaired

n=100 n=100 difference ‘t’ test
Total score 1755 716
10.39
Mean 17.55 7.16
Standard deviation 2.2 3.5
SEM 0.22 0.35
t = 25.1*
95% CI: 17.2 -18 6.5 – 7.9 (198) df
Range 12 - 20 1 -18
Median : 18 7
Normality test KS: 0.21 0.13
P value: 0.0003 0.085
Passed normality NO YES
test
*Significant at P < 0.0001 level

The overall mean awareness score of experimental subjects is (17.55+2.2) is apparently
higher than overall mean awareness score of control subjects (7.16+3.5), the mean
difference being 10.39. The unpaired‘t’ value 25.1 with df (198) is significant at
P<0.0001 level.
- 97 -
TABLE -4:
Comparison of awareness scores of subjects on upper gastrointestinal endoscopy

determined by Mann- Whitney Test.
Experimental Control
Parameters n=100 n=100 Mann-Whitney Test
Sum of ranks of 14903 5197.5 P <0.0001*

awareness scores
* Significant at P <0.0001 level.
Since data of experimental group failed the normality test with P<0.05,
considered using a non parametric test also to prove hypothesis. The obtained P value
using Mann-Whitney test (<0.0001) suggests that the experimental group has a higher
awareness than the control group.
Hypothesis:
The research hypothesis was converted to null hypothesis for the purpose of testing.
There will be no significant difference in the mean post test awareness score
obtained from patients who received a newly designed information leaflet on upper
gastrointestinal endoscopy from the mean post test awareness score obtained form the
patients who did not receive a leaflet on upper gastrointestinal endoscopy as measured by
a structured patient questionnaire at 0.05 levels ( null form).
Since the P value of parametric and non parametric test is extremely significant
(P<0.0001), the high awareness of experimental subjects could be the effect of leaflet
interaction Therefore, the null hypothesis is rejected and research hypothesis is accepted.
- 98 -
TABLE -5:
Comparison of content-wise awareness of experimental and control subjects on

upper gastrointestinal endoscopy.
Experimental Control Unpaired

Content areas n=100 n=100 ‘t’ test
Concept of upper GI endoscopy

• Mean awareness score 4.28 2.27 t = 13.8*
• SD 0.95 1.09 (198)df
• Range of scores 2-5 0-5
Care before the upper GI endoscopy
• Mean awareness score 4.47 2.16 t = 13.9*
• SD 0.79 1.45 (198)df
• Range of scores 2-5 0-5
Care during the upper GI endoscopy

4.48 1.94 t = 16.9*
• Mean awareness score
0.67 1.3 (198)df
• SD
3-5 0-5
• Range of scores
Care after the upper GI endoscopy
4.32 0.79 t = 26.0*
• Mean awareness score
0.9 0.1 (198)df
• SD
1-5 0-4
• Range of scores
*Significant at P <0.0001 level
The overall mean awareness scores of experimental subjects in all the content
areas of upper gastrointestinal endoscopy is higher than the awareness scores of control
subjects as depicted in tabele-5. Therefore the leaflet information could have been
instrumental for the significant increase in the awareness of experimental subjects.
- 99 -
Section-4
SATISFACTION IN CONTROL AND EXPERIMENTAL SUBJECTS

Objective 2:
To compare the satisfaction with the actual experience at the endoscopy unit in the
control and experimental groups after undergoing upper gastrointestinal endoscopy
measured by a structured patient questionnaire.
TABLE-6:
Comparison of subjects with the actual experience at the endoscopy unit measured
after undergoing the upper gastrointestinal endoscopy.
Parameters Experimental Control MD Unpired t test

n=100 n=100
Mean 13.44 10.54
Standard deviation 3.3 3.9

2.8
SEM 0.33 0.39
t=5.47*(198) df
95% CI: 12.7-13.9 9.8-11.3
Range: 6-19 4-19
Medium 13 9
Normality test KS 0.13 0.005
P value 0.059 0.005

Passed normality test? YES NO
*Significant at P<0.0001 level.
The Mean satisfaction scores of experiemental group (13.4+3.3) is higher than
the control group (10.5 +3.9). The obtained P value figured in the above table is
considerd extreemly significant(P<0.0001). This indicates the experimental group is more
satisfied of the actual experience at the endocopy unit than the control group.
- 100 -
TABLE -7:
Comparison of satisfaction score of experimental and control subjects determined
by Mann- Whitney Test.
Parameters Experimental Control Test of significance
n=100 n=100
Sum of ranks 12123 7977 two-tailed P value

<0.0001*
* Significant at P <0.0001 level.
Since data of control group failed the normality test with P<0.05, considered
using a non parametric test. The obtained P value (<0.0001) suggests that the
experimental group has a higher satisfaction than the control group. Since both
parametric and non parametric P value (P<0.0001) is extremely significant the high
satisfaction scores of experimental group could be probably obtained by the effective
interaction with the leaflet information.
- 101 -
TABLE–8:
Association between awareness and satisfaction in experimental and control groups
(within group comparisons)
Experimental group Control group

n=100 n=100
Parameters Awareness Satisfaction Awareness Satisfaction
17.55 13.4 7.16 10.5

Mean
2.18 3.3 3.5 3.9

SD
Maximum score: 20 19 18 19
Minimum score: 12 6 1 4
Median
18 13 7 9
Coefficient of correlation ( r )=0.06NS Coefficient of correlation(r)=0.19*

P = 0.24 P=0.02
NS: Not significant at 0.05 percent level * Significant at P 0.02percent level
From the above values it is apparent that the awareness gained by the leaflet
interaction and the satisfaction expressed by the experimental group did not co vary
effectively. The association awareness and satisfaction of control group is statistically
significant. The awareness and satisfaction did co vary effectively.
From the above table values it is assumed that although the awareness and
satisfaction of experimental group did not co vary as that of control group, the
experimental group has a high satisfaction mean score. It could be probably attributed to
the interaction of experimental group with leaflet information.
- 102 -
TABLE-9:
Agreement and disagreement among subjects on time spent waiting for the
procedure and actual endoscopy procedure measured after undergoing upper
Sub domains of satisfaction N= 100+100=200
Excellent Very Good Fair Chi-

% Good % % Square
% test
Waiting for the procedure Exp 21% 44% 8% 7% X2 =2.34

df (3)NS
Con 25% 40% 3% 2%
Endoscopy procedure Exp 20% 45% 8% 1% X2 =1.64

df (3)NS
24% 43% 33% 0%

Con
NS: Not significant at 0.05 percent level.
Waiting for the procedure: Among the experimental group 21% of subjects
spent < 30 minutes as compared to 25% of control subjects (Excellent), 44% spent 30
minutes to one hour (Very Good)as compared 40% in control subjects 28% of subjects
spent one hour to one and half hours, as compared to 23% control subjects 7% of subjects
spent more than one and half hours as compared to 12% control subjects waiting for the
procedure. The experimental and control groups did not differ significantly in their
satisfaction regarding the time spent waiting for the procedure(X 2 P = 0.5).
Satisfaction with endoscopy procedure: The experimental and control groups did not
differ significantly in their satisfaction regarding the actual procedure(X 2 P = 0.65).
- 103 -
TABLE-10:
Agreement and disagreement among subjects on care during, after the procedure
and information provided measured after undergoing upper gastrointestinal
endoscopy.

% Good % % Square
% test
Care during the procedure Exp 34% 53% 2% 1% X2= 26.6*

df (3)
Con 20% 34% 9% 7%
Satisfaction with the Exp 31% 55% 3% 1% X2= 57.7*

information provided df (3)
Con 13% 22% 9% 6%
Care after the procedure Exp 29% 48% 8% 5% X2= 7.3

df (3) NS
Con 17% 27% 4% 2%
*Significant at P<0.0001percent level NS: Not significant at 0.05 percent level
Care during procedure: The experimental group has higher satisfaction about
the care during the procedure than the control group (P<0.0001).
Satisfaction with the information provided: The experimental group has higher
satisfaction about the information provided to them than the control group (P<0.0001).
Care after the procedure: The experimental group and control group did not
differ in their satisfaction regarding the care after the procedure (P>0.05).
- 104 -
TABLE-11:
Agreement and disagreement among subjects on overall care and their satisfaction
to refer friends and relatives to the same facility measured after undergoing upper

% Good % % Square
% test
Satisfaction with overall care Exp 21% 64% 5% 0% X2= 52*

in the endoscopy unit df (3)
Eon 5% 26% 7% 2%
Would refer friends and

tives to same facility Yes No
Exp 100% 0% X2= 7NS

df (3)
Con 93% 7%
*Significant at P<0.0001 percent level NS: Not significant at 0.05 percent level
Overall rating for the care in the endoscopy unit: The experimental group has
a higher satisfaction about over all care of the unit than the control group (P<0.0001) as
presented in the above table.
Satisfaction to refer friends and relatives to the unit The experimental group
and control group did not differ in their satisfaction to refer their friends and relatives to
our facility as presented in table 9C(P>0.05). Both groups were apparently satisfied.
- 105 -
TABLE – 12:
Responses of experimental group on satisfaction with the content of leaflet

information measured before undergoing upper gastrointestinal endoscopy.
Responses
Satisfaction areas n=100
Yes No
1. Received the leaflet 100%
100%
2. Read the leaflet
100%
3. Was understandable
4. Was useful 100%
5. Is adequate /inadequate in the following

100%
areas
6. Concept about the upper GI endsocopy 100%

7. Care before the procedure 100%
8. Care during the procedure 100%
9. Care after the procedure 100%
10. Should be given to all patients

undergoing the procedure. 100%
The above table depicts that there was 100% satisfaction among the experimental
subjects about the readability, usefulness, understandability and the content of the leaflet
information. All of them expressed that the leaflet should be provided to patients in the
future.
- 106 -
50%
50%
44%
41% 40%
40%
30%
Before
20% 15% After
8%
10%
1% 1%
0%
Excellent V.Good Good Fair
FIGURE -19:
Satisfaction of experimental subjects regarding the leaflet information measured

before and after undergoing upper gastrointestinal endoscopy.
Before undergoing the procedure 44% of subjects opinioned that the leaflet
information was “Excellent” as compared to 41% after the procedure, and as “Very
Good” 40% as compared to 50% after the procedure. On the whole 91% of subjects
opinioned that the leaflet information was “Excellent to Very Good” in relation to the
actual procedure compared to the 84% of subjects who opinioned that the leaflet
information was “Excellent to Very Good” before undergoing the procedure
TABLE- 13:
Linear correlation between before and after opinion of experimental subjects on
leaflet information.
n=100
Parameters Before opinion After opinion Linear regression

Total score 228 231 t = 27.45*
Mean 2.28 2.31 (99)df
*Significant at P<0.0001 level

The above table indicated that there is a significant correlation between the
opinions given before and after undergoing the procedure suggesting that the leaflet was
true in its content as compared to the actual procedure perceived by the experimental
group of subjects.
- 107 -
2%
0%
10%
PAA
AAA
SAA
NAA
88%
PAA – Perfectly Appropriate and Adequate (88%)

AAA – Almost Appropriate and Adequate (10%)
SAA – Somewhat Appropriate and Adequate (2%)
NAA – Not Appropriate and Adequate (0%)
FIGURE- 20:
Adequacy and appropriateness of leaflet information in relation to the actual

procedure as perceived by the experimental group measured after the procedure.
The above diagram presents that 88% percentages of experimental subjects are in
agreement with the leaflet information as perfectly appropriate and adequate, 10% as
almost appropriate and adequate, 2% as somewhat appropriate and adequate.
- 108 -
Section – 5
ASSOCIATION BETWEEN AWARENESS AND SELECTED BASELINE

VARIABLES
Objective 3: To determine the association between the awareness and selected baseline
variables of study subjects.
TABLE -14:
Association between age and awareness of experimental and control groups.
Experimental Control Correlation

Parameters coefficient
n=100 n=100
Mean Age 42 40
SD 13 12.5 r = -0.038NS
Range (years) 20-60 18-60
Mean Awareness score 17.55 7.16
SD 2.1 3.5 r = -0.12NS
P value 0.7 0.23
NS: Not significant at 0.05 percent level
The above table depicts a non-significant association between age and awareness
score of experimental group. The age of the subjects had no impact on the awareness of
subjects regarding upper gastrointestinal endoscopy.
- 109 -
TABLE -15:
Association between sex and awareness of experimental and control groups
Parameters Male Female ‘t’ test

Experimental group
Sample 65 35 t =2.02 NS
Mean awareness score 18 17 (98 )df
SD 1.8 2.4
Control group
Sample 73 27 t = 2.35 NS
Mean awareness score 7.05 7.5 (98) df
SD 3.4 3.8
NS: Not significant at 0. 0 5 percent level
The P values in the table suggest that there is no association between the sex and the
awareness scores of both experimental and control group. So the gender of the subjects did not
influence the awareness of the study subjects.
TABLE-16:
Association between previous endoscopy experience and awareness of experimental

and control groups
Parameters Yes No ‘t’ test
Experimental group
Sample 26 74 t=0.19 NS
Mean awareness score 17.5 17.6 (98)df
SD 2.08 2.2
Control group
Sample 33 67 t = 0.637*
SD 4.2 2.9
NS: Not significant at 0.05 percent level *Significant at P = 0.0024 level.
The obtained P value of experimental group suggests that there is no association between
the awareness score and the previous endoscopy experience. The P value of control group
indicates that the association between the awareness score and the previous endoscopy experience
is statistically significant (P= 0.0024).
- 110 -
TABLE – 17:
Association between inpatients Vs outpatients and awareness of experimental and

control groups.
Parameters Inpatients Outpatients ‘t’ test
Experimental group
Sample 50 50 t = 0.954 NS
SD 2.08 2.25
Control group
Sample 40 60
Mean awareness score 6.3 7.3 t = 2.027(98)df
SD 2.96 3.8
NS: Not significant at 0.05 percent level *Significant at P = 0.045 percent level.
The above table indicates the association between the awareness and the inpatient
Vs outpatient status of experimental group. The obtained P value of control group
suggests that there exists a significant difference in the awareness of outpatients and
inpatients. The outpatient has more awareness on upper gastrointestinal endoscopy.
- 111 -
TABLE -18:
Association between the awareness and education of experimental and control

groups.
n=100 n=100
Mean Mean
awareness awareness
Education f SD f SD
Score Score
Primary 18 17.2 2 26 5.3 2.7

Middle secondary 28 17.1 2 24 6.3 2.6
Higher secondary 26 17.8 2.2 18 6.3 3
Under graduate 16 17.7 2.4 13 8.5 4.3
Post graduate 5 18.6 1.7 12 10.9 4.3
Professional 6 19 0.83 8 8.6 2.33
Any other 0 0 0 0 0 0
ANOVA P = 0.17NS ANOVA P < 0.01*
NS: Not significant at 0.05 percent level *Significant at P<0.01 percent level.
The above table indicates that there is significant association between the
education and the awareness scores of control groups. The association is statistically
significant. But there exists a non-significant association between the education and
awareness of experimental group. From the above values it could be assumed that the
leaflet information was effective in generating awareness in experimental subjects
irrespective of educational qualifications.
- 112 -
TABLE-19:
Association between the awareness and occupation of experimental and control

groups.
Mean Mean
Occupation awareness awareness
f SD f SD
Score Score
Nil 15 17.7 2.2 19 6.9 2.2

Laborer 19 17.3 1.8 20 5 1.8
House wife 19 17.3 2.2 8 7.8 2.2
Retired 4 17 2.7 2 6.5 2.7
Professionals 10 18.8 2.7 17 9.4 2.7
Technicians 15 17 2.3 12 7.9 2.3
Business 10 17 1.7 14 8.5 1.7
Others 8 18.9 1.6 7 5 1.6
NS
ANOVA P = 0.28 ANOVA P < 0.0043*
NS: Not significant at 0. 05 percent level *Significant at 0.0043 level.
The above table indicates that there is significant association between the
occupation and the awareness scores of control groups. The association is statistically
significant.
But the there exists a non-significant association between the occupation and
awareness of experimental group. From the above values it could be assumed that the
leaflet information was effective in generating awareness in experimental subjects
irrespective of their occupation.
- 113 -
6. DISCUSSION
The perspectives of the findings have been discussed with reference to research
problem, conceptual framework, objectives, hypothesis, and assumptions of the study and
with findings of other studies.
This study was designed to assess the effectiveness of an information leaflet on
awareness and satisfaction of patients undergoing upper gastrointestinal endoscopy. To
address the research problem and the objectives of the study the conceptual frame work
used was Imogene King’s theory of goal attainment. Concepts integral to King’s
conceptual frame work and most applicable to present study are perception,
communication, interaction and transaction.
The discussion therefore will be made the following headings:
Section-1
To compare subjects from experimental and control groups, in relation to the baseline
variables.
Section-2
To compare the awareness of experimental and control groups before undergoing the
upper gastrointestinal endoscopy.
Section-3
To compare the satisfaction of patients with actual experience at the endoscopy unit
Section - 4
To determine the association between awareness and selected baseline variables
- 114 -
Section-1
To compare subjects from experimental and control groups, in relation to the
baseline variables
The subjects in the present study constituted 200 patients undergoing upper
gastrointestinal endoscopy 100 each in experimental and control group. From the view
point of the conceptual framework the baseline perceptions of clients were assumed to be
the factors likely to influence the dependant variable namely the awareness of patients on
upper gastrointestinal endoscopy. According to King, perceptions are related to past
experiences, socio-economic groups, biological inheritance and educational background.
King also added that if perceptual accuracy exists the goal will be met. Referring to this
assumption in the King’ conceptual framework the controlling factors for the recruitment
of the subjects were the inclusion and exclusion criteria set at the beginning of this study.
The table shows various categories of data covering the proportions of subjects that fall
into baseline variables like age, sex, education, occupation, previous endoscopy
experience and inpatient Vs outpatient status. Therefore the Chi-square statistics was
computed to compare two sets of categories in experiential and control group. It was also
so essential to determine the homogeneity of two group variables since the hypothesis
being tested was that the mean awareness obtained from patients who received newly
designed leaflet information on upper gastrointestinal endoscopy will not be significantly
higher than the mean post awareness score obtained from the patients who did not receive
leaflet. Also the awareness score of control group was considered as the baseline
measurement to compare the awareness scores of experimental group after the leaflet
intervention.
- 115 -
The computed probability levels (P>0.05) indicated that selected baseline
parameters of the experimental and control groups were comparable, It means that the
difference between the two groups were not statistically significant at 0.05 percent level.
Thus the Chi-Square test enabled the investigator to decide whether a difference in
proportions of magnitude is likely to reflect a real experiential effect, that is, leaflet
information on the awareness and satisfaction or only a chance fluctuation. Further more
the demographic data of experimental and control groups indicated that the mean age of
experimental group was 42 + 12.5 and of the control group was 40 +13 indicating more
middle aged subjects in the studied population. One study30 considered only ages
between 18-90. Among the sex distribution males were 65% in experimental group and
73% in control group reflecting greater proportion of males in the study subjects. Among
the subjects of experimental group 26% and of control group 33% had previous
endoscopy experience. Almost equal proportion of inpatients and outpatients were
referred for the procedure. While considering the education of the subjects, majority of
them belonged to primary to higher secondary education in experimental and control
groups. All occupational categories were referred for this procedure. All the accessed
studies related to this topic considered only ages between 18-90, gender and previous
endoscopy experiences. Among the present study subjects 40.5% used Kannada, 25%
Tamil, 10.5% Telugu, and 24% used English as their common language for reading and
writing. Above findings are consistent with the previous researches61, 63, 66 that patient’s
instruction material should be designed according to literacy rate and education and
socio- economic background of the patient population to whom it will be addressed in the
future.
- 116 -
Section -2
To compare the awareness scores of experimental and control groups.
The first objective of the study was to compare the awareness of patients in the
control and experimental groups before undergoing upper gastrointestinal endoscopy.
According to the conceptual frame work of present study the concerns of client and nurse
were converged into a mutual goal setting – to communicate with patient’s information
on upper gastrointestinal endoscopy by processing the required information into a leaflet.
Prior to the dissemination of leaflets the investigator evaluated the effectiveness of leaflet
interaction using a prospective case control design. Post test only experimental design
was composed of two randomly assigned groups but neither of which was pre- tested in
the before period of time. The independent variable- leaflet information was introduced
to experimental group and withheld from the control group. This design was particularly
useful in the present study setting because the population studied would not be available
to pretest as 50-60 % patients were outpatients and also the investigator wanted to recruit
both inpatients and outpatients for better accuracy and generalization of the findings from
the population studied. In this design the score of control group was referred to as the
baseline measures. The scores of experimental group was the outcome measure of the
dependent variables- awareness and satisfaction that captured the outcome of interaction
with leaflet information.
Referring to the third concept of conceptual framework of the study, the
interaction took place between the experimental group of patient and newly processed
information leaflet on upper gastrointestinal endoscopy. The goal of leaflet information
was to bring concise, precise and standard information and instruction to exchange with
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patients undergoing upper gastrointestinal endoscopy. If perceptual accuracy existed in
the experimental group transaction is the outcome, which also is the evaluative
component of interaction.
Therefore, the investigator measured the goal outcome of interaction at a point
after a minimum 12 hours of leaflet interaction, but before undergoing upper
gastrointestinal endoscopy. An unpaired’ test was computed to ascertain difference in the
awareness scores of experimental and control groups. The mean awareness score of
experimental group was 17.55 +2.9 and mean awareness score of the control group was
7.16 + 3.5. The two – tailed P value was <0.0001which is considered extremely
significant. Importantly, that’s’ test assumes that data are sampled from population that
follows normal distribution. The investigator ascertained whether the sampling
distributions are very close to a pattern of frequency distribution known as normal
(Gaussian) distribution. Since this play a predominant part in medical and biological
research and a particular use of this normal distribution is made whenever we have a
large sample. That’s’ test assumption was tested using the method Kolmogrov &
Smirnov (KS). The computed P value suggested that the experimental group failed the
normality test and the control group passed. Since the experimental group did not have
frequency distribution plotted a symmetric bell shaped curve it indicated the curve is
skewed or distorted. Since the testing of hypothesis constituted the heart of this empirical
investigation that were quantitative and also to place greater confidence in hypothesis
testing it was also suggested doing a non parametric test. Although, the statisticians
disagree about the utility and virtues of non paramedic test over parametric test which is
more powerful, the more moderate position in this debate, and one that the investigator
thought reasonable was that non parametric tests are also useful when the distribution of
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data is skewed. The Mann Whitney non parametric test (P<0.0001) suggested that the
experimental group has a higher awareness than the control group.
An unpaired’ test also was computed to assess whether there is a significant
difference in the experimental and control groups regarding the awareness in the areas of
concept of upper gastrointestinal endoscopy, care before, care during, care after the
procedure which were dealt in the leaflet information. All the computed P values
(<0.0001) are extremely significant. So the null hypothesis was rejected, the research
hypothesis, then, came to be accepted with evidences from the P values of parametric
and non parametric test, that is, the awareness of experimental group is significantly
higher than the control group regarding upper gastrointestinal endoscopy, which was
measured before undergoing the procedure. This could be probably due to an effective
interaction between leaflet information and the experimental group. It means that
interaction component of the conceptual framework could be the causative factor in
increasing the awareness of experimental group. The awareness score of control group
(7.16 + 3.5) also supported the assumption of the study that patient may have some basic
information regarding upper gastrointestinal endoscopy that can be supplemented.
The above evidences from the present study amplify the findings of the previous
researches in the areas of information giving and awareness before medical and nursing
procedures. Early and recent researches also support the findings of the present study that
giving appropriate information given in a format in conjunction with verbal explanation
can improve the quality of care.
A previous study75 support the findings of the present study that patients desire
and want written information. Another study26 reported that written information is a cost-
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effective intervention that complements verbal advice given by health care professionals
as reflected in the present study. Although not all studies show consistent results some
studies of psychological preparation have shown significant benefits on variety of
measures of stress which was not the main focus of consideration in this study. The
present study identified the same findings of a study32 conducted which evaluated the
effect of giving both sensory and procedural information, to patients prior to gastroscopy
and turned to have beneficial efforts.
There is evidence7, 8 to indicate that patients view communication as an issue that
is central to their care as was seen by the high awareness score in the experimental group
of the present study. In particular, they appear to rate the receiving of information high
which was also true in the present as well as many other studies10, 11. The present study
and another study24 conducted in Australia suggested that provision of information in a
format will, maximize knowledge and keep anxiety to a minimum as indicated by the
Mean difference of 10.39 from control group to experimental group. Almost all patients
of present study and other studies found such information were to be of help. It is
interesting to consider a study where he welcomed a sample of 131 patients undergoing
minor gynecological surgery, special preparatory information was given and its timing
and format of presentation were examined. Over 90% of patients approved of this type of
preparation for surgery which was also similar in the present study too. Like in the
present study on the effectiveness of leaflet information in an another study the most
preferred type of information was a booklet containing composite of sensory, procedural
and reassuring information. Some studies17, 21 suggest that the effect of information varies
according to the individual’s coping mechanisms which were not evident in the present
study as no variables affected the awareness scores of experimental group. Some
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studies63,66 argue that most adults respond to stress through information seeking coping
mechanisms which was evident in the control group of subjects of the present study.
Beneficial effects of information giving were experienced by those who receive sensory
and procedural information. The findings of some studies30,31 indicate that fewer distress
behaviors are displayed by patients provided with sensory information in a written format
as compared with patients provided with less information which was also the findings of
the present study. There is some evidence in the present study when compared to similar
studies to suggest that patients who received sensory information prior to a procedure
significantly were more realistic with actual experiences than subjects who received few
procedural information from the counter staff. An experimental study7 looked at the
outcome of giving structured written information and reported that less pain and
discomfort was expressed during the procedure by patients who received information
compared with those who did not.
Some studies6, 7,9 identified widespread dissatisfaction with regard to transmission
of information from patient to doctor and doctor to patient which was carefully addressed
by the present study. One of the benefits of the present study is that it supports the
findings and investigations of the previous researches that written information materials
were instrumental in increasing awareness about a pending procedure. More importantly,
the present study findings also added its major contribution to the body of knowledge
which argues that information giving and generating awareness in patients before taking
consent is one of the major responsibilities of doctors and nurses. The present study
findings together with previous research findings73, 74, 75 suggest that providing patients
with professional and targeted information content in a written form can significantly
increase the awareness about that pending procedure.
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Section -3
To compare the satisfaction with the actual experience at the endoscopy unit in the
control and experimental groups
The second measurement point in this study was after the subjects undergoing
upper gastrointestinal ensoscopy. The investigator systematically studied the reported
data of experimental group and compared with control group to determine the perceptual
success of leaflet information as it was the most unique feature of this study. This study
considered effectiveness as the utility of leaflet information in the real world, that is,
endoscopy unit. Although it is a noble concept available in the literatures only two
studies were available to support the present study79,86 because most of the past studies
examined either the type of information required by the patients or the cognitive success
of information provided in the areas of knowledge gained.
From the view point of conceptual framework of the study, if leaflet and
experimental group made transaction goals must have been obtained, that is, generating
awareness about upper gastrointestinal endoscopy. If goal was obtained, satisfaction
would occur. This assumption would lead one to consider the second objective of the
study as the dual effect of leaflet interaction that is increased awareness leading to
enhanced satisfaction towards the actual procedure at the endoscopy unit. Unpaired’ test
was computed to compare the satisfaction of experimental and control groups and the
obtained mean satisfaction score of experimental group (13.44 + 3.9) was higher than the
mean satisfaction score of control group (10.54 + 3.9) which was significant at P <0.0001
level. Here too, the data of experimental group failed the normality test, considered also
using a non parametric test. The Mann Whitney test P value (<0.0001) suggests that
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experimental group has a higher satisfaction with actual experience than the control
group. So it could be argued that the higher satisfaction in the experimental group which
is significant at P<0.0001 level would be the work of leaflet information in the
experimental group of subjects.
Investigator further studied the statistical difference in the sub-domains of
satisfaction among the experimental and control groups rather to compare control and
experimental groups in their sub areas of satisfaction. For this purpose the Chi-square test
was used to determine which were the sub-domains of actual experience where the
experimental and control groups agreed and disagreed. The experimental group had a
higher satisfaction in the areas of care during the procedure, information provided in
relation to the actual procedure and overall care at the endoscopy unit compared to
control group which was significant at P<0.0001 level. In fact these findings were similar
to a satisfaction survey21 of patients who had a gastrointestinal procedure in 2002 in USA
and found that patient satisfaction is generally quite high, with rating of care given during
the procedure topping the list. There were few similar findings in another study75
showing that simple easily understood information presented in timely passion would
lead to satisfaction.
The two groups of the present study did not differ in their opinion regarding the
time spent waiting for the procedure, endoscopy procedure, care after the procedure, and
satisfaction to refer friends and relatives to the same facility as proved by non significant
P values, meaning to say, control group even without leaflet information was satisfied
with some of the aspects of actual care. So one of the highlights of this study was that
both groups were more or less preferred to come to the same facility as observed in a
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survey study79 which concluded that patient’s opinion reflected in their intentions to
return to same facility, is an indicator of satisfaction..
Another aspect that was inherent to the first and second objectives of the study
was to find out the effect of awareness on the satisfaction of experimental and control
group separately. Although the satisfaction of experimental group was higher than the
control group the awareness gained from the leaflet information and the satisfaction with
actual experience did not co vary (r = 0.06; P=0.24). One could not conclusively say that
written information was effective in increasing awareness and satisfaction with equal
magnitude. Here the investigator did not succeed in accessing empirical studies which
evaluated the effect of awareness on the satisfaction with actual procedure. One could
also assume from the present study that leaflet has succeeded to get a high satisfaction in
the areas of information provided and the care during the procedure (<0.0001) when
compared to control group.
Another focus of attention within the purview of research problem was to
ascertain the correlation between the scores given before and after the procedure by the
experimental group on leaflet information. Linear regression determined how related
were the leaflet information to the actual experience at the endoscopy unit as perceived
by the experimental group and found significant with ‘ t’ value 27.45(99df) at P<0.0001
level. Therefore, it could be assumed that the leaflet information was true to its content
in relation to actual procedures at the endoscopy unit. These findings were supported by
a study20 in Norway which evaluated a newly developed brochure on endscopic
procedures and assessed the degree of correlation between the written information and
the actual procedure as perceived by the patient. The post-endoscopy response of the
same study indicated that the patients had received a realistic description of the procedure
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and rated as “excellent” or “very good” by 87% of the respondents where as the post-
endoscopy response of the present study were rated as “Excellent” or , “Very Good” by
91% of subjects. In addition the post endoscopy rating as “Excellent” or “Very Good”
was given by 91% experimental subjects when compared to their pre- endoscopy
rating(84%).
Similar to the present study, a gastroenterology unit of Florence the leaflet
together with a multiple choice questionnaire also evaluated client’s satisfaction with the
information provided in 100 clients undergoing a colonoscopy over a two-month period
in 1988. The results of survey27 like the result of the present study findings suggest that
the leaflet has been instrumental in client learning about the procedure. At present, all the
patients booked for colonoscopy receive the leaflet in their homes.
Another interesting opinion of the experimental group of the present study was
on the adequacy and appropriateness of leaflet information in relation to the actual
procedure the experimental group experienced. Among them 88% experimental subjects
agreed that the leaflet is perfectly appropriate and adequate when compared to the
findings found in a patient-opinion survey23 on informed consent for gastrointestinal
endoscopy conducted in September 2004 on 11.639 patients at Three River Centre in
Israel, 66% of the patients were satisfied with the written consent process. The above
finding reveals the effectiveness of leaflet information in increasing the satisfaction
which was thought to be an effect of gaining increased awareness.
Surprisingly, all the experimental group of subjects (100%) of present study
expressed before undergoing the procedure that the content in the leaflet was readable,
understandable, useful, and adequate in the areas of concept of upper gastrointestinal
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endoscopy, care before, care during and care after the procedure and it is preferable to
disseminate to all patients before undergoing the procedure. The present study findings
match with the findings of a survey conducted in Israel, where 98% of the patients were
satisfied with consent form and 97% felt it was clear and comprehensive and 80% of the
patients felt it was reassuring. A prospective study24 in Austria also investigated the
success of preoperative information on Laproscopic Cholecystectomy by interviewing
200 patients, 97% indicated to wish detailed information, 84% indicated a high level
satisfaction with presented information where as in the present study all the experimental
subjects were satisfied with the leaflet information. Also there are evidences from the
researches74 conducted to evaluate the readability and usability of information leaflets
that patient information leaflets are poor and are in language that is difficult for the public
to understand. The findings of the present study was still more satisfying reflecting a
100% agreement on the readability and the usability of the newly designed information
leaflet on upper gastrointestinal endoscopy. Many researches61-63 suggested that
considerable time, effort and user involvement are required to produce acceptable and
appropriate information leaflets for the patients. These suggestions were considered very
much from the beginning of this study, indeed, the present study was built on the findings
of the many previous studies.
In the light of above findings it is good to highlight a paper presented by Michael
Sheppard33 at a university of England indicating considerable differences between
satisfied and not satisfied clients in the service received and their perception. Patient
satisfaction relate clearly to the use of interpersonal skills such as those of
communication, empathy, listening, openness and genuiness. This is an area where the
investigator succeeded to a certain extent along with the written format.
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The strength of this study is that the investigator evaluated the effectiveness of a
newly designed leaflet information on upper gastrointestinal endoscopy from different
angles exclusively based on patient reported data. No published studies had done as
many as extensive statistical inferences to evaluate the effectiveness of an information
leaflet . No attempt was made from the part of the investigator to be with the study
participants, indeed, they were allowed to report their opinion in a free environment.
While the investigator was actively engaged in recruiting the subjects during the first
stage of the data collection, the participants were actively engaged in completing the
second, third and fourth stages of the data collection. The investigator picked up the data
collection instruments only when the participants handed over. Therefore, one could
conclusively say that the above findings are drawn from the free response of the patients
who participated in the study.
Section -4
Association between the awareness and the baseline variables of experimental and
control groups
The third objective of the study was to determine the association between the
awareness and the selected baseline variables of experimental and control groups. Since it
was assumed that the baseline variable would probably influence the awareness levels of
patients attempts were made to determine the impact of these variables on the awareness
of control and experimental groups. The‘t’ test and ANOVA revealed that there existed a
non-significant association between the age, sex, education, occupation, previous
endoscopy experience and the inpatient Vs outpatient status of the experimental subjects.
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In all the above associations the probability values were not significant at 0.05 levels. The
baseline awareness scores obtained from the control group suggested that there is
significant association between the age and sex of control group. But there was a
statistically significant association between the awareness and the education (ANOVA
P<0.01), occupation (ANOVA P<0.01), previous endoscopy experience (P=0.0043), and
outpatient status (P= 0.045) of control group. Tukey kramer multiple comparison test
was computed to identify the specific difference among the subgroups. The association is
significant primary Vs professional (P<0.01), middle secondary Vs professional
(P=<0.01), higher secondary Vs professional (P<0.01). So the difference in the awareness
of postgraduates compared with primary, middle secondary and higher secondary is
statistically significant at 0.05 levels. The awareness score of laborer Vs professionals
also is significant (P<0.01) and the total group ANOVA P value is (0.0043) considered
significant. Therefore, it could be assumed the baseline awareness scores of control
group were closely associated with educational qualifications, professional training,
previous endoscopy experience and the outpatient status of the subjects as found in a
study to assess the effects of video on knowledge of patients undergoing colonoscopy,
patients’ age and education did not affect video education; however the sex and previous
experience affected the findings. As and above it is an added advantage to the
effectiveness of the leaflet information to generate awareness to all categories of
experimental group studied irrespective of their selected baseline variables.
In a study by Clement and Melby30 which determined the amount and type of
information given to patients before, during and after undergoing gastroscopy
investigations. There were statistically significant differences between the information
acquired by younger and older patients prior to the procedure and nurses appeared to be
the most important source of information for older patients while information leaflet was
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perceived as the most important source of information for younger patients. In another
study31 found that younger patients read the information leaflet than the older patients
where as in the present study there were no such differences. However, Ley30 argued that
age is not the determination factor in terms of how much information they remember, if it
is produced in an understandable form.
Thompson et al investigated the information provided to patients undergoing
gastroscopy procedures in Northern Irelan31 patients received most of the procedural
information from nurses and they recognized the importance of providing sensory
information, patients were generally satisfied with the information provided where as the
patients received most of the information from leaflet information topping in the list.
Other study findings in South Australia24 suggested that written information is successful
in this aim only in a proportion of education in the population, because it requires at least
basic literacy as well as the motivation to read the material provided. Surprisingly the
written leaflet information studied in the present study proved truly beyond such findings.
It is also important to note, however, researches indicate that written information
provided for routine procedures do not adequately inform patients , perhaps to due to the
fact that readability information leaflets was too difficult for the ordinary lay person. The
major strength present study is that all the experimental subjects expressed satisfaction
regarding the leaflet information and the awareness gained was irrespective of age, sex,
education, occupation, previous endoscopy experience and inpatient Vs outpatient status.
From the above discussions it is very clear that this study ascertained the
effectiveness of leaflet information on the awareness level of experimental compared to
the awareness level of control group through an unbiased sample drawn from that
population of patients undergoing upper gastrointestinal endoscopy. In this simple
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random sampling method, each member of patient population undergoing diagnostic
upper gastrointestinal endoscopy from 21.2.05 to 31.3.05 had an equal chance of being
selected into the sample. The allocation sequence into experimental and control group
was generated by the random placement of sealed, thoroughly shuffled, sequentially
numbered envelope by a person who is not involved in this study. Strength of this study
is that generalization is possible since a large sample study was conducted. The size of
the sample reproduced the characteristics of population studied with greatest possible
accuracy. There was no substitution in originally selected sample. When sealed
sequentially numbered envelop reached 200 the investigator analyzed self-reported
questionnaire in order to qualify for analysis. Since some of the questionnaire has to be
disqualified due to gross inadequacy in the filling of questionnaire the investigator
recruited some more samples by placing randomized covers. This design safeguarded
also to an extent the extraneous variables that could have interfered with research in
human subjects like history, maturity, bias, and reaction or interaction effect of pretest.
To the question paused by the investigator, whether other patients waiting for the
procedure were the source of information, none reported “yes” rather all reported “no”
also safeguarded the internal validity . Indeed it could be argued that this study was less
biased and more reliable.
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7. CONCLUSION
During the study, it was observed that all patients undergoing upper
gastrointestinal endoscopy had a need for information to make an informed decision.
Patients from control group had lack of awareness as was evident from their awareness
mean % scores (35.8%) when compared to the mean % awareness score of experimental
group 87.75%. The mean % difference between the awareness scores of two groups was
51.75%. The similarity of two groups’ variables makes one possibly conclude that the
two groups came form the same population. Therefore the high awareness scores of
experimental group could be the work of leaflet information on the already existing
perceptions in that group, generating a further awareness in all areas of upper
gastrointestinal endoscopy procedure. The leaflet information made a commendable
contribution in increasing the awareness of experimental group regarding the care after
the procedure as compared with the awareness of control group.
There was a high satisfaction for experimental group compared with control
group which was statistically significant. The Chi-Square test computed for test of
differences indicated that the control and experimental group agreed on the sub domains
of satisfaction, which were waiting for the procedure, endoscopy procedure, care after the
procedure, and satisfaction to refer friends and relatives to the same facility. But there
was a disagreement on sub domains of satisfaction like care during the procedure,
information provided prior to the procedure in relation to the actual experience at the
endoscopy unit and overall satisfaction with the endoscopy unit performance, meaning to
say that the experimental group had a high satisfaction in these areas (P <0.0001).
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Even though one could assume that leaflet has succeeded to get a high
satisfaction in the areas of information provided, from the statistical point of view the
satisfaction scores and the awareness scores of experimental group did not co vary
effectively. These findings of the study revealed that leaflet information and the
subsequent awareness gained could not be claimed to be the single most variable that
would enhance the satisfaction with actual experience rather multiple factors are to be
considered in the course of time. Hence, one cannot conclusively say that increase in
awareness would result in equal increase in satisfaction with equal magnitude.
It also was noticed that the experimental group perceived the content of
the leaflet information as closely related to the actual experience at the unit. Indeed, it
could be argued that the leaflet information was true to its content as and what was
required for the specific procedure. all the experimental subjects before undergoing the
procedure recognized the content of leaflet information as readable, useful, and expressed
that it should be disseminated to all patients in the future. Among them 88% agreed that it
is adequate and appropriate and 8% agreed that it was almost adequate and appropriate in
relation to the actual procedure.
From the above findings the investigator would like to conclude that the newly
designed leaflet on upper gastrointestinal endoscopy was effective in generating more
awareness about the pending procedure had a high recognition, acceptability and utility in
the experimental group of subjects. It also could be presumed that leaflet was acceptable
and comprehensible to the particular sample studied which was a true representation of
multi-lingual and multi-cultural population that come to our facility daily. Indeed it was
a useful study and that it was beneficial to make the information leaflet available to the
patients undergoing diagnostic upper gastrointestinal endoscopy procedure.
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8. SUMMARY
The primary aim of the study was to assess the effectiveness of an information
leaflet on the awareness and satisfaction of patients undergoing upper gastrointestinal
endoscopy.
The objectives of the study were:
before undergoing upper gastrointestinal endoscopy measured by a structured
patient questionnaire.
the control and experimental groups after undergoing upper gastrointestinal
endoscopy measured by a structured patient questionnaire.
variables of both control and experimental groups.
This study attempted to examine the following research hypothesis:
There will be no significant difference in the mean post test awareness score
obtained from patients who received a newly designed information leaflet on upper
gastrointestinal endoscopy from the mean post test awareness score obtained form the
patients who did not receive a leaflet on upper gastrointestinal endoscopy as measured by
a structured patient questionnaire at 0.05 level ( null form).
The conceptual framework used for the study was the Imogene King’s theory of
goal attainment. Concepts integral to King’s conceptual framework and most applicable
to present study were perception, communication, interaction and transaction.
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Review of literature on studies related to information giving, patient
instructional material informed consent and decision making, awareness, patient
satisfaction and upper gastrointestinal endoscopy helped the investigator to develop a
leaflet on upper gastrointestinal endocopy.
In view of the problem and the objectives of the study an outcome research
approach was considered to most appropriate. The research design used for this study
was a prospective, randomized, controlled, post test only experimental design with
two data collection points. The independent variable in this study was a newly
designed information leaflet and the dependent variables were the awareness before
the procedure and satisfaction after the procedure. The setting of the study was the
endoscopy unit of SJMCH and the population studied was patients undergoing
diagnostic upper gastrointestinal endoscopy in the same facility. The sample size
consisted of 200 patients 100 each in control and experimental groups. The only
controlling factors of this study were the inclusion and exclusion criteria set at the initial
phase of the study. Subjects were recruited and randomized into both groups by drawing
sealed, thoroughly shuffled, sequentially numbered envelope. The independent variable
dealt with four major issues: concept, care before, care during and care after the
procedure. A self report quantitative questionnaire was used to ensure the
effectiveness of leaflet information on the awareness of patients prior to undergoing the
procedure. To facilitate the collection of patient satisfaction data an instrument developed
by Group health Association of America was used. The content validity and reliability
of the patient instruments were established prior to the pilot study. The instruments and
the leaflet were piloted in 20 patients before the main study. Ethical approval to
undertake this study was granted from the intuitional research ethical committee and the
research committee of college of nursing.
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MAJOR FINDINGS OF THE STUDY:
Findings related to baseline variables:
The two groups were comparable in terms of all baseline characteristics(P>0.05).
Demographic data of experimental ad control groups indicated that the mean age of
experimental group was 42 + 13.5 and of the control group was 40 +13. This finding is
consistent with previous researches that although the upper gastrointestinal can affect any
age from young children to the very elderly the onset of problem is more common in the
middle aged population. Among the sex distribution in the groups males were 65% in
experimental group and 73% in control group. The females were 35% in experimental
group and 27% in control group. The greater proportion of males in both groups reflects
the findings of the past researches that men are more susceptible to upper gastrointestinal
problems at a ration 3:1.
Findings related to the awareness in control and experimental groups
The mean awareness score of experimental group was 17.55 +2.9 and mean
awareness score of the control group was 7.16 + 3.5. The two – tailed P value was
<0.0001which is considered extremely significant. The mean awareness scores of
experimental group in all the content areas of leaflet information was significantly higher
(P<0.0001) than mean awareness scores of control group. Hence hypothesis could be
rejected. This also implies that the information leaflet could have been instrumental in
increasing awareness scores of experimental group.
Findings related to the satisfaction of control and experimental groups.
The mean satisfaction score of experimental group (13.44 + 3.9) was higher
than the mean satisfaction score of control group (10.54 + 3.9). The computed P value
was <0.0001 which is considered extremely significant. Although the satisfaction of
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experimental group is higher than the control group the awareness gained from the leaflet
information and the satisfaction with actual experience did not co vary. These findings of
the study revealed that leaflet information and the subsequent awareness gained could not
be claimed to be the single most variable that would enhance the satisfaction with actual
experience rather multiple factors are to be considered in the course of time. Hence, one
cannot conclusively say that increase in awareness would result in equal increase in
satisfaction with equal magnitude.
Findings related to leaflet information
The experimental group perceived the content of the leaflet information as
closely related to the actual experience at the unit. Indeed, it could be argued that the
leaflet information was true to its content as and what is required for the specific
procedure. It could be assumed that the leaflet information was true to its content in
relation to actual procedures at the endoscopy unit. Among them 88% agreed that the
leaflet is perfectly appropriate and adequate and 10% agreed that the leaflet information
is almost appropriate and adequate 2% agreed that the leaflet information is somewhat
appropriated and adequate. Moreover, all the experimental group of subjects (100%)
expressed before undergoing the procedure that the content in the leaflet was readable,
understandable, useful, and adequate in the areas of concept of upper gastrointestinal
endoscopy, care before, care during and care after the procedure and it is preferable to
disseminate to all patients before undergoing the procedure.
Findings related to the association between awareness and baseline variables
There existed a non-significant association between the age, sex, education,
occupation, previous endoscopy experience and the inpatient Vs outpatient status of the
experimental subjects. The baseline awareness scores obtained from the control group
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suggested that there is no significant association between the age and sex of control
group. But there was a statistically significant association between the awareness and the
education occupation previous endoscopy Therefore; it could be assumed the e baseline
awareness scores of control group were closely associated with educational
qualifications, professional training, previous endoscopy experience and the outpatient
status of the subjects. Interestingly, it is an added advantage to the effectiveness of the
leaflet information to generate awareness to all categories of experimental group studied
irrespective of their selected baseline variables.
IMPLICATIONS OF THE STUDY
The implications made in this study are vital to patients, nursing practice,
endoscopist, nursing administration, hospital administration, nursing education and
medical and nursing research.
Patients:
Provision of verbal information provides a back-up system in cases where patients
are not provided with information or cannot recall information. Written information
enables patients to access the information they want at the time when they want it. The
leaflet on upper gastrointestinal endoscopy is presented in accessible language. Providing
information before-hand regarding the procedure helps the patients undergoing upper
gastrointestinal endoscopy to cope with the pending procedure.
Nursing practice:
It is a useful study and it is beneficial to make the information leaflet available to
all patients undergoing diagnostic upper gastrointestinal endoscopy. This study will lead
to a major change in the quality of information giving at the endoscopy unit of SJMCH,
producing a leaflet on upper gastrointestinal endoscopy that would be more informative
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and attractive in four languages: Kannada, Tamil, Telugu and English and which would
prove more satisfactory to patients. Nurses and other members of the health team would
deliver information through well-designed patient information leaflet in conjunction with
oral information provision.
Endoscopists:
The need to provide relevant and understandable patient information prior to
diagnostic and therapeutic procedure is being recognized and fulfilled by giving a
concise, precise and standardized information leaflet. Provision of written information
fulfills the medico-legal considerations and consumer’s right for the relevant information.
A systematic study of endoscopic practice with special attention to patient-centered data
identified the effectiveness information leaflet in real world. Patient centered data may
reveal strength and deficiencies that might be unknown to an endscopist.
Nursing administration:
Leaflet information is an important cost-effective source of patient instruction.
The dissemination of written information would take place in a co-ordained manner that
patients receive the leaflet at the appropriate time and all know who is responsible for its
dissemination. The copies of this can be made available at endoscopy unit.
Hospital administration
Client satisfaction is of fundamental importance as a measure of the quality of
care because it gives information on the provider’s success at meeting these client values
and expectations which are matters in which the client is the ultimate authority.
Satisfaction with endoscopy unit performance can be used to guide quality improvement
efforts. The measurement of satisfaction, therefore, is an important tool for research,
administration and planning
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Nursing education:
The information leaflet designed by this investigator can be used as an
instructional tool for nurse educators in imparting knowledge to students with regard to
preparation of patients undergoing diagnostic upper gastrointestinal endoscopy.
Nursing research:
The study supported other research, which has indicated that one way of
facilitating improved information giving is through the greater use of written information.
It would contribute relevant additional information to the body of knowledge. The
suggestions and recommendations can be utilized by other researchers for studies in the
same field. The outcome may serve as guidelines in preparing module in the other
endoscopy areas like colonoscopy, sigmoidoscopy etc.
RECOMMENDATIONS
Profitable ventures for further research on this topic would be:
1. Studies documenting the effect of leaflet information on the physiological,
anxiety and stress level of patients should follow.
2. A descriptive study also should examine perceptions of nurses and other
professional regarding the importance of typical patient education content for
patients undergoing upper gastrointestinal endoscopy.
3. Studies documenting the effect of leaflet information on the actual behavior of
patients during the procedure, including cooperation, success of procedures and
compliance with instructions should follow.
4. The provision of visual information by video also could be studied in contrast to
leaflet information
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5. A descriptive study must obtain patient’s views about their care allowing free
expression of their perceptions and experiences in order to utilize full range of
patient’s values and experiences to provide quality service.
6. The same type of study could be conducted in the future in view of helping
patients undergoing different diagnostic procedures.
LIMITATIONS OF THE STUDY
Qualitative study data which examined the knowledge requirements of patients
undergoing upper gastrointestinal endoscopy in SJMCH was not available in compiling
the new information leaflet.
PERSONAL LEARNING
Information giving is an area on which nurse should concentrate on in order to
gain credibility. To take this role successfully, nurses need to develop a clear
definition of their role in patient education. The cognitive success of leaflet
information was an increased awareness about the procedure. One of the important
psychological benefits of leaflet information was an increased patient satisfaction
regarding the care in the facility and the information provided. The study suggests
that providing patients with a professional, personal and targeted educational system
can significantly increase their satisfaction to return to the same health care facility.
Nurses should design information materials in an easy- to- read language considering
the literacy rate and education of all clients to whom it is addressed. Consent needs to
become an active ‘informed decision’ in which patients make choices based on
comprehensive information. The patient care, their perceptions of actual procedure,
their expectations and satisfaction must be at the forefront of any piece of service
provided by nurses.
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INFORMED CONSENT
ST.JOHN’S COLLEGE OF NURSING

ST.JOHN’S NATIONAL ACADEMY OF HEALTH SCIENCES
BANGALORE – 34
WELCOME DEAR FRIEND.
Introduction
I am Sr. Lilly Joseph, a second year MSc Nursing student of St.John’s College of
Nursing. I have developed an information leaflet for patients undergoing upper gastrointestinal
endoscopy. The leaflet would provide information about various aspects of procedure that you
are undergoing.
I want to study how effective this information leaflet would be in enhancing your
awareness related to upper gastrointestinal endoscopy. I want to find out also the correlation
between the information received and the actual procedure as perceive by you when you
underwent the upper gastrointestinal endoscopy. Hence some of you will receive a newly
developed information leaflet on upper gastrointestinal endoscopy and an appointment form and
some of you will receive only on this day. A thoroughly shuffled envelope will indicate whether
you will receive the information leaflet or not. This is the way the study will be done.
What is expected of you for this study is:

¾ To read and understand the information leaflet about upper gastrointestinal endoscopy.
¾ (Some of you will receive written information in your own language).
¾ If you cannot read it, you would ask anyone to read it to you and tell you the content.
This information will be useful to you for the success of the procedure that you have to
undergo.
¾ To read and understand the information on the “request for endscopy form”.(All of you
will receive an appointment form written en English and Kannada).
¾ To come for the prescribed procedure at least one hour before the appointment time.
¾ As you wait for your test, you may fill a questionnaire. (Please understand that it is only
to assess your awareness regarding upper gastrointestinal endosopy. So you have to fill as
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truthfully as you can you need not write your name. The time required to complete this
questionnaire will e 10 minutes. A pen or pencil will be provided to you. You have to
place a tick in a box corresponding to the appropriate option,
¾ Then, you will go for the upper gastrointestinal endoscopy.
¾ At the end of your resting period and as you waits for the typed copy of the result of your
test; you have to fill the questionnaire – 2. This is to assess how related are the written
information in the newly developed leaflet and the actual procedure as perceived or
experienced by you. The time required to fill this questionnaire within 5 minutes.
I assure you that the information provided by you, will be kept strictly confidential and will be
used only to assess the effectiveness of newly developed information leaflet on upper
gastrointestinal endoscopy though some of you will receive it after the procedure.
If you agree to the above conditions, kindly sign the paper,
then I will proceed with the research.
I understand that I will be part of a research that will focus on the effectiveness of information
leaflet for patients undergoing upper gastrointestinal endoscopy. I understand that this study
will help the researcher to draw conclusion on the benefit of an information leaflet for patients
under going upper gastrointestinal endoscopy and make it available for all those who undergo
this procedure in the future. So I am giving my consent to participate in this research which
will be conducted by Sr.Lilly Joseph, the second year MSc Nursing student of St.John’s
College of Nursing, knowing fully what is expected of me in this study.
SIGNATURE………………………………………
DATE……………………………………………
I appreciate your cooperation.

Thanking you,
Sr.Lilly Joseph
Second year MSc Nursing student
St. John’s College of Nursing
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INFORMATION ON
UPPERGASTROINTESTINAL
ENDOSCOPY
GASTROENTEROLOGY DEPARTMENT
ST.JOHN’S MEDICAL COLLEGE HOSPITAL
BANGALORE – 34
- 149 -
Dear…………………………………………
Your doctor has recommended that you have an upper gastrointestinal endoscopy.
WHAT?
Upper G.I endoscopy refers to the examination of upper gastrointestinal tract: the
esophagus, stomach and duodenum using an endoscope.
ENDOSCOPE?
A tube-like, thin, flexible device with a light on one end attached to a color TV camera
WHY?
To discover the reasons for:
• Abdominal pain
• Anemia.
• Bleeding from the digestive tract
• Chronic heartburn
• Fullness of stomach
• Indigestion
• Nausea, vomiting
• Trouble in swallowing
• Unexplained chest pain
IS THIS TEST SAFE?

¾ Safer & simpler comparing to surgery.
¾ Highly effective diagnostic technique.
¾ Complications are extremely low.
WHERE?
At the Endoscopy unit of SJMCH Outpatient Room No.28.
WHO DOES?
A GASTROENTEROLOGIST who has received special training in diagnosing the diseases of
the digestive system and in the safe and proper operation of an endoscope.
HOW LONG?
The test lasts for 5-15 minutes.
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VERY ESSENTIAL
Your cooperation & How?
BEFORE THE TEST
Don’t:
¾ drink or eat anything for at least 10 – 11 hours .
¾ use tobacco, within 2 hours of the test.
¾ take antacids on the day of the test.
¾ If you are a diabetic, don’t take your medications including insulin in the morning of
the test.
It means:
¾ If your test is scheduled in the morning, not to eat or drink anything after 10 PM on
the night before the test.
¾ If your test is scheduled in the afternoon, you can have only liquids: juice, coffee, tea
for breakfast, then don’t take anything by mouth.
Do Take:
¾ All your regular medications with water in the night before the test.
Bring With You:

¾ Appointment form
¾ X-rays/scan
¾ Current medications
Come With:
¾ A family member or a friend with whom doctor can freely discuss the results of tests.
¾ You can go home safe with.
Plan your time:
¾ Arrive 30 minutes before your appointment.

¾ Stay an hour after the test.
Consent:
You will need to sign a “consent form” before the endoscopy begins, which will state that
you understand and agree to the test.
DURING THE TEST

A nurse will:
¾ Look after you through out
¾ Assist you to remove dentures & glasses.
¾ Give you an anesthetic gargle
¾ Position you on the left side
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¾ Insert a mouth piece.
¾ Help you to relax.
¾ Give intravenous sedation if needed.
Doctor will:
¾ Gently & painlessly pass an endoscope through your mouth down to your stomach.
¾ View clearly the esophagus, stomach & duodenum in the TV camera.
¾ Take painlessly tiny biopsies using the endoscope, if needed.
You must:
¾ Bend your neck accordingly.

¾ Swallow the endoscope.
¾ Breath through the nose.
You may feel:
¾ A bitter taste, numbness & excessive saliva in the mouth after the gargle.
¾ Little discomfort while inserting & removing the endoscope.
¾ Putting air into the stomach.
¾ A humming noise from the equipment.
¾ May feel slightly bloated with air.
¾ Sore throat for the rest of the day.
AFTER THE TEST

¾ Don’t eat or drink for about 1 hour, then may drink fluids.
¾ After the numbness is completely off, resume your normal diet.
CAUTION FOR 24 HOURS

If you were sedated during the procedure:
Don’t
¾ Drive a vehicle.
¾ Drink alcohol beverages.
¾ Travel alone.
¾ Go to work.
THE RESULT
¾ Your doctor will discuss the test findings and any recommended treatment.
¾ A typed copy will usually be given to you about 15 minutes.
¾ Biopsy result will be given on the next appointment day.
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If you have any concerns or questions regarding this procedure,
please do not hesitate to consult your doctor or a nurse.
We welcome and appreciate your feedback.
For any enquiries contact: 22065239.
Open: Monday to Saturday from

8.30 am to 5 pm.
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Post test – 1
PATIENT INSTRUMENT –1
QUESTIONNAIRE TO PATIENTS BEFORE UNDERGOING

UPPER G 1 ENDOSCOPY
SECTION “A” BASELINE VARIABLE
INSTRUCTIONS TO THE PARTICIPANTS:

¾ The purpose of this section is to collect information related to the research.
¾ You need not write your name.
¾ Please read the questions and options and place a tick in in one box
only, which corresponds to your single best option.
¾ Please do not tick in more than one box.
¾ Please answer as truthfully as you can.
1. GENDER
‫ ٱ‬Male ‫ ٱ‬Female
2. AGE
‫ ٱ‬less than 18 years
‫ ٱ‬18 – 30 years
‫ ٱ‬31 – 40 years
‫ ٱ‬41 – 50 years
‫ ٱ‬51 – 60 years
‫ ٱ‬more than 60 years
3. EDUCATION
‫ ٱ‬Primary
‫ ٱ‬Middle secondary
‫ ٱ‬Higher secondary
‫ٱ‬ college – Undergraduate level
‫ ٱ‬College – Post graduate level
‫ ٱ‬Professional level
‫ ٱ‬Any other (please write)
4. OCCUPATION
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‫ ٱ‬Nil
‫ ٱ‬Laborer
‫ ٱ‬Housewife
‫ ٱ‬Retired
‫ ٱ‬Professional
‫ ٱ‬Technician
‫ ٱ‬Business
‫ ٱ‬Any other (please write)
5. Did you undergo an upper gastro intestinal endoscopy in the past?
‫ ٱ‬YES ‫ ٱ‬NO
6. If your answer is YES, when did you undergo?.
‫ ٱ‬6 months before
‫ ٱ‬One year before
‫ ٱ‬Two years before
‫ ٱ‬I do not remember
7. Are you admitted no, in St. John’s Medical College Hospital?
SECTION – “B”
QUESTIONNAIRE TO IDENTIFY THE SOURCES OF INFORMATION
REGARDING UPPER G.I ENDOSCOPY
INSTRUCTIONS TO THE PARTICIPANTS:

¾ You are requested to place a tick in the box corresponding to the single
best option.
¾ Please do not tick in more than one box
QUESTIONS
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1. Did you receive yesterday together with your appointment forms written
information regarding upper gastrointestinal endoscopy, which you
have to undergo today?
[INFORMATION ON UPPER GASTROINTESTINAL ENDOSCOPY with two
pictures on the cover page, written in your own language].
‫ ٱ‬YES [If your answer is YES, please answer questions 2-8]
‫ ٱ‬NO (If your answer NO, please do not answer questions 2- 7,
but answer question number: 8.)
2. If you have received, did you read those information?
3. Were you able to understand the information given in the leaflet?
4. Do you think the leaflet was useful to you?
5. Do you think the leaflet information was adequate in the following areas
of care?
1. Concept of upper G.I endoscopy ‫ ٱ‬YES ‫ ٱ‬NO
2. Care before the procedure ‫ ٱ‬YES ‫ ٱ‬NO
3. Care during the procedure ‫ ٱ‬YES ‫ ٱ‬NO
4. Care after the procedure ‫ ٱ‬YES ‫ ٱ‬NO
6. Do you think the leaflet should be given to all patients who will have to
undergo upper G.I endoscopy?
7. To express your over all opinion about the leaflet what rating will you
give?
‫ ٱ‬Excellent
‫ ٱ‬Very good
‫ ٱ‬Good
‫ ٱ‬Fair
8. Did you receive any information regarding the procedure you have to
undergo today from the following persons? (Please tick in the box
corresponding to your option).
- 156 -
If your answer is YES, what rating will you give to the information provided by
them?
Please circle | the single most appropriate score.
Very Poor Good Very Excellent
Poor Good
Doctors ‫ ٱ‬No ‫ ٱ‬Yes 1 2 3 4 5
Nurses ‫ ٱ‬No ‫ ٱ‬Yes 1 2 3 4 5
Office staff of ‫ ٱ‬No ‫ ٱ‬Yes 1 2 3 4 5
endoscopy
counter
Other patients ‫ ٱ‬No ‫ ٱ‬Yes 1 2 3 4 5
who are also
waiting for the
procedure
Any others ‫ ٱ‬No ‫ ٱ‬Yes 1 2 3 4 5
(please write)
SECTION “C”
AWARENESS QUESTIONNAIRE REGARDING
UPPER GASTROINTESTINAL ENDOSCOPY
INSTRUCTIONS TO PARTICIPANTS:
¾ Please answer all questions

¾ There are a total of 20 questions
¾ Each question has 5 options. Please place a tick in the box corresponding
to the single best option.
¾ Please do not tick in more than one box.
QUESTIONS
1. What is upper gastrointestinal endoscopy?
- 157 -
Upper G.I endoscopy refers to the examination of:
1.1 ‫ ٱ‬The esophagus, stomach & duodenum
1.2 ‫ ٱ‬The ileum, jejunum & cecum
1.3 ‫ ٱ‬Pancreas, Liver, Spleen
1.4 ‫ ٱ‬Nose, windpipe, lungs
1.5 ‫ ٱ‬Do not know
2. What are the purposes of upper G.I endoscopy?

To discover the reasons for:
2.1 ‫ ٱ‬Abdominal pain, anemia, indigestion
2.2 ‫ ٱ‬Bleeding from the digestive tract, chronic heart burn, fullness of
stomach
2.3 ‫ ٱ‬Indigestion, nausea, vomiting
2.4 ‫ ٱ‬Trouble in swallowing, unexplained chest pain
2.5 ‫ ٱ‬All the above
3. What is your understanding about this procedure?

3.1 ‫ ٱ‬Not a surgery or operation
3.2 ‫ ٱ‬Safer & simpler than surgery
3.3 ‫ ٱ‬Highly effective diagnostic test
3.4 ‫ ٱ‬Complications are extremely low
4. What is the role of your co-operation for the success of this test?
4.1 ‫ ٱ‬Very essential
4.2 ‫ ٱ‬May be essential
4.3 ‫ ٱ‬May not be essential
4.4 ‫ ٱ‬Not essential
5. Who is performing upper gastrointestinal endoscopy?
5.1 ‫ ٱ‬Gynecologist
5.2 ‫ ٱ‬Gastroenterologist
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5.3 ‫ ٱ‬Neurologist
5.4 ‫ ٱ‬Urologist
5.5 Do not know
6. Before the test, you should not drink or eat for at least
6.1 ‫ ٱ‬2 to 4 hours
6.4 ‫ ٱ‬10 to 11 hours
7. If your test is scheduled in the morning you can take all your regular
medications
7.1 ‫ ٱ‬Two hours before the test
7.2 ‫ ٱ‬In the morning of the test
7.3 ‫ ٱ‬In the might before the test
7.4 ‫ ٱ‬Any time before the test
8. When you come for the test, you must bring with you
8.1 ‫ ٱ‬Appointment form
8.2 ‫ ٱ‬X-rays & scan if you have
8.3 ‫ ٱ‬Current medications that you take regularly
9. You are expected to arrive at the endoscopy unit of St. John’s Medical
College Hospital, Outpatient Room No. 28 at least
9.1 ‫ ٱ‬30 minutes to one hour before your test
9.2 ‫ ٱ‬Two hours before the test
9.3 ‫ ٱ‬Three hours before the test
9.4 ‫ ٱ‬Four hours before the test
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10. You will need to sign a “consent form” before the endoscopy begins.
What is the reason?
10.1 ‫ ٱ‬To state that you understand and agree to the test.
10.2 ‫ ٱ‬To ensure that you arrived here
10.3 ‫ ٱ‬To calm your fear & anxiety
10.4 ‫ ٱ‬To permit you for endoscopy procedure
11. As a preparation for your test, a nurse will

11.1 ‫ ٱ‬give you an anesthetic gargle
11.2 ‫ ٱ‬assist you to remove dentures & glasses
11.3 ‫ ٱ‬position you on the left side
11.4 ‫ ٱ‬insert a mouthpiece and help you to relax
12. During the test you will be cared by a

12.1 ‫ ٱ‬Nurse
12.2 ‫ ٱ‬Student
12.3 ‫ ٱ‬Priest
12.4 ‫ ٱ‬Social worker
13. During the test, you are expected to help the passage of Endoscope by
13.1 ‫ ٱ‬holding the tube
13.2 ‫ ٱ‬looking at the tube
13.3 ‫ ٱ‬swallowing the tube
13.4 ‫ ٱ‬biting the tube
14. During the test, your doctor will

14.1 ‫ ٱ‬gently & painlessly pass an endoscope through your mouth down
to your stomach
14.2 ‫ ٱ‬view clearly upper digestive tract in the TV camera
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14.3 ‫ ٱ‬take painlessly tiny biopsies using the endoscope if needed
14.4. ‫ ٱ‬All the above
14.5 ‫ ٱ‬Do not above
15. What is your attitude towards the test
15.1 ‫ ٱ‬I am safe & secure in the expert presence of doctors & nurses
15.2 ‫ ٱ‬I am uncertain what will happen to me
15.3 ‫ ٱ‬I am anxious and tensed.
15.4 ‫ ٱ‬I am afraid of complications
16. After the anesthetic gargle & test you may feel
16.1 ‫ ٱ‬bitter taste and numbness in the mouth
16.2 ‫ ٱ‬excessive saliva in the mouth
16.3 ‫ ٱ‬slightly bloated with air
17. After the test, it is normal for the rest of the day to experience
17.1 ‫ ٱ‬Chest discomfort
17.2 ‫ ٱ‬Sore throat
17.3 ‫ ٱ‬Stomachache
17.4 ‫ ٱ‬Headache
18. After the test, you should not eat or drink for
18.1 ‫ ٱ‬about one hour

18.2 ‫ ٱ‬about two hours
18.3 ‫ ٱ‬about three hours
18.4 ‫ ٱ‬about four hours
19. You may resume your normal solid diet, when the numbness is
19.1 ‫ ٱ‬still feeling

19.2 ‫ ٱ‬partially off
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19.3 ‫ ٱ‬almost off
19.4 ‫ ٱ‬completely off
20. A typed copy of the result of your test will be given to you in about
20.1 ‫ ٱ‬5 minutes

THANK YOU FOR COMPLETING THIS QUESTIONNAIRE
ANSWER KEY FOR AWARENSS QUESTIONNAIRE

ON UPPER G.I ENDOSCOPY
SCORE
Q. No. Answer Single most appropriate Other options Total score
- 162 -
option
1 1.1 1 0 1
2 2.5 1 0 1
3 3.5 1 0 1
4 4.1 1 0 1
5 5.2 1 0 1
6 6.4 1 0 1
7 7.3 1 0 1
8 8.4 1 0 1
9 9.1 1 0 1
10 10.1 1 0 1
11 11.5 1 0 1
12 12.1 1 0 1
13 13.3 1 0 1
14 14.4 1 0 1
15 15.1 1 0 1
16 16.4 1 0 1
17 17.2 1 0 1
18 18.1 1 0 1
19 19.4 1 0 1
20 20.2 1 0 1
20 20 20 20
POST TEST – 2
PATIENT INSTRUMENT – 2
- 163 -
PATIENT SATISFACTION QUESTIONNAIRE TO PATIENTS AFTER UNDERGOING UPPER
GASTROINTESTINAL ENDOSCOPY
SECTION D – PATIENT SATISFACTION
Dear Friend,
The purposes of this section is:
1) To know your overall satisfaction regarding the actual performance of the
endoscopy unit as perceived by you.
2) To know the adequacy and appropriateness of written information given in the
information leaflet on upper gastrointestinal endoscopy [if you have received] in
relation to the actual performance of the staff of endoscopy unit as perceived by
you.
Instructions to the participants:
• There are 4 options for each questions

• Please select the single most appropriate option and tick √ against it in the
column.
• I would appreciate your frankness
• Please answer as truthfully as you can.
QUESTIONS
1) The courtesy, respect and sensitivity of the office staff of the endoscopy unit at
your request for an appointment.
Excellent Very Good Good Fair
2) The length of time spent waiting at the endoscopy unit to get an appointment.
less than 10 minutes 10 to 20 minutes
21 to 30 minutes more than 30 minutes
3) The length of time spent waiting for the procedure, today.
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less than 30 minutes
30 minutes to one hour
1 hour to 1 1/2 hours
More than 1 1/2 hours .
4) The thoroughness, carefulness, gentleness and the friendliness of the doctor who
performed your procedure.
5) The assistance, the care and the friendliness of nurses and supporting staff who
attended on you.
6) Adequacy of explanations of what was done for you and answers to all your
questions.
7) The adequacy of assistance, care and sensitivity of nurses after the procedure.
8) Overall rating of the performance of our endoscopy unit.
9) Would you consider referring your relatives and friends to this unit if their doctors
requested for upper gastrointestinal endoscopy having done for them.
Yes No
Please Notice:
- 165 -
[Question numbers 10 & 11 are applicable to you, only if you received an information
leaflet on upper gastrointestinal endoscopy, at the time of your appointment yesterday].
10) The appropriateness and adequacy of information in the leaflet about upper
gastrointestinal endoscopy in relation to the actual performance as perceived by
you.
[Please indicate by ticking √ against the most appropriate score]
Not appropriate &adequate somewhat appropriate & adequate
Almost appropriate & adequate perfectly appropriate & adequate
11) Overall rating of the information written in the information leaflet in relation to
the actual performance as perceived by you.
12) What are the other information you would have liked but did not get?
…………………………………………………………………………………………
…………………………………………………………………………………………
…………………………………………………………………………………………
…………………..
13) Would you have any other comments?
………………………………………………………………………………………………
………………………………………………………………………………………………
……………………………………………
Thank you for completing this questionnaire.
- 166 -

Medical Surgical Nursing Assignment

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“A Study to assess the effectiveness of an information leaflet on

awareness and satisfaction of patients undergoing upper

gastrointestinal endoscopy at St. Johns Medical College Hospital

LILLYKUTTY M.J (Sr.Lilly Joseph)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,

In partial fulfillment of the requirements for the

MASTER OF SCIENCE IN NURSING

MEDICAL SURGICAL NURSING

Under the guidance of

Prof. Mrs. MADONNA BRITTO M.SC. (N)

ST.JOHN`S COLLEGE OF NURSING, BANGALORE –34,

DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “A Study to assess the

effectiveness of an information leaflet on awareness and satisfaction of patients

undergoing upper gastrointestinal endoscopy at St. Johns Medical College Hospital

(SJMCH), Bangalore” is a bonafide and genuine research work carried out

by me under the guidance of Prof. Mrs. MADONNA BRITTO, Dean of

Nursing Faculty of Rajiv Gandhi University of Health Sciences, Principal

& Head of Medical Surgical Nursing of St.John’s College of Nursing

and Dr. ABRAHAM KOSHY, Professor & Head of Gastroenterology

Department, St. John’s Medical College Hospital, Bangalore.

Lillykutty M.J (Sr.Lilly Joseph)

This is to certify that the dissertation entitled “A Study to assess the

effectiveness of an information leaflet on awareness and satisfaction of

patients undergoing upper gastrointestinal endoscopy at St. Johns

Medical College Hospital (SJMCH), Bangalore” is a bonafide and

genuine research work done by Lillykutty M.J (Sr.Lilly Joseph) in

partial fulfillment of the requirement for the degree of Master of Science

Signature of the Guide: Signature of the Co- Guide:

Date:30.05.2005 Date: 30.05.2005

This is to certify that the dissertation entitled “A Study to

assess the effectiveness of an information leaflet on awareness and

satisfaction of patients undergoing upper gastrointestinal endoscopy at

St. John’s Medical College Hospital (SJMCH), Bangalore” is a

the guidance of Prof. Mrs. MADONNA BRITTO, Dean of Nursing

Faculty of Rajiv Gandhi University of Health Sciences, Principal & Head

of Medical Surgical Nursing of St. John’s College of Nursing.

Signature of the Principal:

Declaration by the candidate

I hereby declare that the Rajiv Gandhi University of Health Sciences,

dissertation /thesis in print or electronic format for academic /research

Date:30.05.2005 Signature of the candidate

©Rajiv Gandhi University of Health Sciences, Karnataka

Dedicated to God Almighty

Prof. Mrs. MADONNA BRITTO

My appreciation and thanks

Dr. ABRAHAM KOSHY

HOD & PROFESSOR

ST.JOHN’S MEDICAL COLLEGE HOSPITAL

I am particularly appreciative of his valuable suggestions, helpful discussions, honest

Rev. Fr. THOMAS KALAM, DIRECTOR, SJNHS

Rev. Fr. SEBASTIAN, ADMINISTRATOR, SJMCH

Dr. MARY OLLAPPALLY, MEDICAL SUPERINTENDANT, SJMCH

REV.SR.RIYA, NURSING SUPERINTENDANT, SJMCH

My heart felt thanks

Miss. Mildred Rani, VICE PRINCIPAL for her helpful discussions.

I remain with folded hands

Prof. Mrs. H.Lalitha, MSc Coordinator

Following teachers from whom I learnt Nursing Research and Bio-statistics:

Prof. Mrs. Mary Ann Charles,

Prof. Mrs. Preethy D’Souza,

Prof. Mrs. Jasmine Benny

Special word of thanks and appreciation to Prof.Mrs.Jasmine Benny for her

I acknowledge the liberal library assistance by the following individuals: