RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE - II

PROFORMA FOR REGISTRSTION OF SUBJECTS FOR

DISSERTATION

1 Name of the candidate Ms. SRUTHY SUNNY

and address(in block letters)

SAHYADRI COLLEGE OF NURSING,

SAHYADRI CAMPUS, NH-48, ADYAR,

MANGALORE-575007.

2 Name of the institution

SAHYADRI COLLEGE OF NURSING,

SAHYADRI CAMPUS, NH-48, ADYAR,

MANGALORE-575007.

3 Course of study and subject M.Sc. NURSING, CHILD HEALTH NURSING

4 Date of admission to course 26/7/2010

5 Title of the topic:

A STUDY TO ASSESS THE EFFECTIVENESS OF

LOCAL COLD APPLICATION ON PAIN RESPONSE DURING

INTRAVENOUS PROCEDURES AMONG CHILDREN IN

SELECTED HOSPITAL, MANGALORE.

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6.BRIEF RESUME OF THE INTENDED WORK

Introduction

Illness and hospitalization expose children to

unfamiliar and unpleasant feelings. Since children have little experience with and

comprehension of the pain and disease process, such negative feeling can cause

intimidation and anxiety for them1. Millions of children experience these

procedures which cause considerable distress. Children requiring needle stick

such as injections, IV catheters and blood sampling view these procedure as

frightening and is a significant source of pain2.

Intrusive procedures such as venipuncture are

really a stressful event for children. Venipuncture in the paediatric population can

be the most distressing event associated with medical encounters3.

Nurses have most frequent contact with children

presenting for non emergency illness and injury care and they spend more time

with patient in pain than any other health care professionals. A nurse has to help

the children through such procedure. The nurse caring the child during procedure

has a double task. One is helping the child and parents effectively and the other is

ensuring the effectiveness of procedures4.

Nonpharmacological procedures or technique to

reduce procedure related pain and avoid potential drug’s side effects are

generally less expensive and can be performed independently by a nurse5.A

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number of non pharmacological techniques such as distraction, relaxation, guided

imagery and cutaneous stimulation provides coping strategies that may help to

reduce pain perception, make pain more tolerable, decrease anxiety and enhance

the effectiveness of analgesics. Among these measures, proper use of cutaneous

stimulation can reduce pain perception. Cutaneous stimulation is performed by

several methods such as simple rhythmic rubbing, use of pressure or electric

vibrator, application of cold and hot at site before injection, which has been

significantly valued in various sites. Cold application relieves pain by slowing the

ability of pain fibres to transmit pain impulse6.

6.1 Need for the study

Normally hospitalized child will come across many

painful procedures during their childhood, especially procedures like injections,

blood sampling etc. These procedures are painful and moreover create a fearful

memory in child’s mind and make the child afraid of future hospitalization.

Intravenous injection is the method to administer medication or fluid into

circulatory system through intravenous line7.

Increasing evidence has demonstrated that pain from

venipuncture and intravenous cannulation is an important source of paediatric

pain and has a lasting impact. Ascending sensory neural pain pathways are

functioning in preterm and term infants, yet descending inhibitory pathways seem

to mature postnatally. Consequently, infants may experience pain from the same

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stimulus more intensely than older children. In addition, painful perinatal

procedures such as heel lancing or circumcision have been found to correlate with

stronger negative responses to venipuncture and intramuscular vaccinations

weeks to months later. Similarly, older children have reported greater pain during

follow-up cancer-related procedures if the pain of the initial procedure was poorly

controlled, despite improved analgesia during the subsequent procedures.

Fortunately, both pharmacologic and nonpharmacologic techniques have been

found to reduce children's acute pain and distress and subsequent negative

behaviours during venipuncture and intravenous catheter insertion. This review

summarizes the evidence for the importance of managing paediatric procedural

pain and methods for reducing venous access pain8.

Intravenous procedures causes moderate to severe pain

in most of the children and also in adults. Most of the paediatric unit will have

some method to reduce pain to a great extent by using various non

pharmacological methods. Among that local cold application comes under

cutaneous stimulation and is very effective and practicable before IV procedures.

Children early relieve from pain with various non

pharmacological methods especially with cutaneous stimulation. With cold

application, pain related to IV injection and IV infusion will reduce as a result of

numbness and it also reduces the pain transmission ability of pain fibers6.

A study conducted on children who were inpatients in

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a tertiary care hospital on prevalence and source of pain in paediatric patients.

The study indicated that 49% of the 200 subjects reported clinically significant

level of severe pain, 21% of these subjects had clinically less significant level of

usual pain during first 24 hours, So the study concluded that the cause of pain

may be variable from sources as diseases, surgery and IV line9.

Cold application and hot application will relieve pain

and promote healing. An application of cold is considered to slow the ability of

pain fibers to transmit pain impulses10.A similar study shows refrigerant local

anaesthetic spray reduced injection pain during DPT immunization11.

The investigator during her clinical experience felt that

children are often exposed to painful procedures on admission to hospital. One

such common procedure is intravenous procedure which is very painful to

children. Thus, the investigator is interested to emphasize on the measure of pain

relief by cold application to reduce pain among children during intravenous

procedures. With this intention, the investigator has taken steps to find the

effectiveness of local cold application on pain response during intravenous

procedures.

6.2 Review of literature

A study was conducted to assess the effect of local refrigeration prior

to venipuncture on pain related response in school age children. Eighty children

with 6-12 years of age were selected and divided into two groups as test group

and control group. In test group injection site was refrigerated for 3 minute using

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ice bag before injection and in control group it was performed according to

normal routine. By using CHEOPS, oucher’s scale, and with physiological and

behavioural responses, was found that average pain intensity in local refrigeration

is much less compared to pain intensity in control group. The results of this study

suggest that the use of local refrigeration prior to venipuncture can be considered

an easy and effective intervention of reducing venipuncture-related pain12.

A study to investigate the effect of local dry cold application on the

occurrence of bruising, hematoma and pain at the injection site in subcutaneous

low molecular weight heparin injection was conducted on a sample of 63

patients, who were divided into four treatment groups. In the first group cold was

not applied. Cold was applied to the injection site for five minutes before the

injection in the second group and for five minutes after the injection in the third

group. In the fourth group it was applied to injection site for five minute pre and

post injection. Following each injection the patient’s pain intensity and duration

were measured at 48 hours and 72 hours after the injection. Result showed that a

hematoma did not occur at the injection site of any subject and there was no

significant difference in the incidence or size of bruise among the groups;

however the subject’s perception of pain was significantly less with ice

application13. .

A study was conducted to evaluate the effect of local cold therapy and

distraction in pain relief during penicillin intramuscular injection in children.

Ninety children with age 5-12 years who had penicillin injection

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intramuscularly in a health centre were studied. The samples were divided into

three groups: the first group received local cold therapy, the second group

received distraction therapy and the third group received routine care. By using

pain intensity scale, the average pain score in local cold therapy was 26.3, in

distraction was 34.3 and in control group was 83.3 respectively, which shows that

local cold was effective in reducing IM injection related pain14.

A double blind study was conducted to find out the efficiency of

refrigerant topical anaesthetic in reducing injection pain in preschool children

experiencing routine DPT Immunization on a sample of 90 subjects aged 4-5 1/2

years, who were randomly assigned to one of three groups;(a)refrigerant topical

anaesthetic;(b)placebo topical spray and;(c)control. Pain was subjectively

measured using a four –point visual analogue scale. Both the refrigerant topical

anaesthetic spray and the placebo spray significantly reduced injection pain15.

A prospective, crossover randomized study on the efficacy of ethyl

chloride spray and ice cube for the control of pain induced by the antibiotic skin

test was studied on 50 healthy adult volunteer with an intradermal skin test in

both arms after different pre-treatments as applying ice cubes and vapocoolant

spray. The pre-treatment pain and discomfort after the intradermal skin injection

using a visual analogue scale was assessed. The mean pain score after the skin

test were 32.4±17.6mm and 54.7 ±22.4mm, for the ice cube and vapocoolant

spray pre treatment respectively (P<0.0001). The mean discomfort score during

pre treatment were 20.0 ± 15.5mm for use cube and 10.5 ± 11.5mm for

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vapocoolant spray (P<0.0001). The study concluded that ice cube application was

significantly more effective than the vapocoolant spray in reducing the pain of

antibiotic skin test16.

A study was designed to determine the effect of application of cold or

heat on the sensation of pricking pain based on automatic response. Electrical

stimulation was applied to the anti brachium of subjects with an artificial pricking

pain and the skin blood flow and skin conductance level at the fingertip was

measured. Pain sensation was evaluated using the visual analogue scale. Pain

stimulation produced a significance increase in skin conductance level and

significant decrease in blood flow at both ante brachial and brachium.

Applications of cold to the stimulation site using an ice water pack decreased

blood flow and skin conductance level responses. The results suggests that

application of cold promotes relief of pricking pain sensation and suppression of

autonomic responses and where as hot had little effect17.

An open label random split face trial was conducted to measure the

extent with which applying spot cooling device reduces patient discomfort

related with pain and ecchymosis in patients undergoing hyaluronic acid dermal

filler injection .Forty samples were selected between the age of 35-65 years with

moderate to severe nasolabial fold. Prior to injection, topical cooling system was

set at 300 F and a cooled applicator was applied for 20 seconds on nasolabial fold.

A control using a noncooled applicator was applied for 20 seconds on the other

nasolabial fold. Use of the cooling system was associated with mean pain

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reduction of 61% immediately after injection, 70% one hour after injection, 42%

three hour after injection compared to control as measured by visual analogue

pain scale and concluded that the cooling provides adequate pain management18.

A quasi experimental study was used to determine whether cold therapy

decrease the perceived pain associated with IM injection in children. Sample of

40 children with age 10 to 80 years was randomly assigned to control and

experimental group. The experimental group had an ice pack placed on the

injection site for 15 minutes prior to injection and control group with normal

routine care. Children who receive cold therapy showed significant reduction in

IM injection pain19.

6.3 Problem statement

A STUDY TO ASSESS THE EFFECTIVENESS OF LOCAL COLD

APPLICATION ON PAIN RESPONSE DURING INTRAVENOUS

PROCEDURES AMONG CHILDREN IN SELECTED HOSPITAL,

MANGALORE.

6.4 Objectives of the study

The objectives of the study are to :

 Assess the pain response of children during intravenous procedures in

experimental group.

 Assess the pain response of children during intravenous procedures in

control group.

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  Assess the effectiveness of local cold application on pain response during

intravenous procedures among children.

 Find the association between the pain response of children with selected

demographic variables.

6.5 Operational definitions

Effectiveness :

In this study effectiveness refers to the reduction

of pain response by children after local cold application prior to intravenous

procedures as measured by Children’s Hospital of Eastern Ontario Pain Scale

(CHEOPS).

Local cold application:

In this study local cold application refers to the

application of ice cube covered with gauze over the site of intravenous procedure

for a period of 3 minute prior to intravenous procedures.

Pain response:

In this study pain response refers to the response of children

to pain stimuli as manifested by cry, facial expression, child verbal response,

torso, touch and movement of legs.

Children:

In this study children refers to children between 3-12 years

of age who are admitted in the selected hospital.

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Intravenous procedures:

In this study IV procedure refers to insertion of IV

cannula as well as drawing blood samples.

6.6 Assumptions

The study assumes that,

 Intravenous procedure is a routine painful procedure for

children.

 Cold decreases the sensitivity of tissue and create a sense

of numbness.

6.7 Delimitations

The study delimited to,

 Children who are admitted to selected hospital. Mangalore.

 Children who are available at the time of data collection.

6.8 Hypotheses

H1: The mean pain score of experimental group after local cold application

will be significantly lower than the mean pain score of control group.

H2: There will be significant association between pain score of children

with selected demographic variables.

7. MATERIALS AND METHODS

7.1 Source of data

The data will be collected from children during intravenous procedures

admitted in selected hospital.

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7.1.1 Research design

The research design selected for the study is post test only control group

design

E X O1

C - O2

E - Experimental group

C - Control group

X - Intervention in the form of local cold application prior to intravenous

procedure.

O1 - Observation of the experimental group after local cold application.

O2 - Observation of the control group

7.1.2Setting

The study will be conducted in the paediatric wards of selected hospital,

Mangalore.

7.1.3Population

Population includes children who are admitted in paediatric wards of

selected Hospital, Mangalore and receiving IV procedures.

7.2 Methods of data collection

Data will be collected by using :

 Demographic Proforma.

 Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS).

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7.2.1 Sampling procedure

Non probability purposive sampling technique will be used to select the

samples.

7.2.2 Sample size

The sample for the study comprises of 60 children with age group of 3-

12 yrs; 30 children for experimental group and 30 children for control group who

are undergoing intravenous procedures in selected hospital, Mangalore.

7.2.3 Inclusion criteria

Inclusion criteria for sampling refers to the children,

 Within the age group of 3-12years.

 Admitted to paediatric ward and undergoing intravenous

procedures in selected hospital, Mangalore.

 Who are willing to participate in the study.

7.2.4 Exclusion criteria

Exclusion criteria for sampling refers to children,

 Who are chronically ill.

 Who are mentally handicapped.

 Who are admitted with surgical conditions.

7.2.5 Data collection methods

 The investigator will obtain formal permission from the

selected hospital.

 The purpose of the study will be explained to the children

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 and their parents and informed written consent will be

obtained from their parents.

 After administering the intervention pain will be assessed

by using children’s Hospital of Eastern Ontario Pain Scale.

7.2.6 Data analysis plan

 demographic data will be analysed using descriptive statistics such as

mean, median and standard deviation,

 Effectiveness of interventions with local cold application will be done by

using independent ’t’ test.

 Association between pain score and selected demographic variables will

be calculated by using Chi- square test.

7.3 Does the study require any investigations or interventions to be

conducted on patients or other humans or animals?

Yes. In this study researcher has to apply ice packs on site prior to IV

injection for relieving pain.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

.yes. Ethical clearance will be obtained from the institutions

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8.REFERENCE

1. Baucher H, Woring C, Vinci R. Effect of skin refrigerant and age on pain

responses of infants receiving immunization. Research in nursing and health

1991;87(4):544-548.

2. Kharach S. Pain treatment: Opportunities and challenges. Achieves of

paediatric and achieves of medicine 2003;157(11):1054-1056.

3. Caty S, Elberton M, Ritchie JA .Use of projective techniques to assess the

young children appraisal and coping response to venipuncture. Journal of society

of paediatric nursing 1997;2(2):83-92.

4. Breman A. Caring for children during procedure. Paediatric nursing journal

1997;20(5):451-457.

5. Jacobson AF. Intradermal normal saline solution, self selected music and

insertion difficulty effect in IV insertion pain. Journal of acute and critical care

2000;28 (2):114-122.

6. Wong DL, Hockenberry MJ. Text book of infants and children. 7th ed. St.

Louis:Elsevier ;2003.993-995.

7. Potter PA, Perry AG. Fundamentals of nursing. 6th ed. St. Louis: Mosby;2005.

902.

8. Department of paediatrics-Washington university. Clinical implication of

unmanaged needle insertion pain and distress in children.St.Louis:2005.

9. Cummings EA, Reid GJ, Finley G.A. Prevalence and source of pain in

paediatric patients. 1996;68(11):56.

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10. Ball JW, Bindler RC. Paediatric nursing: caring for children.3rd ed.

Newjeresy: Prentice;2003.

11. Maikler VE. Effect of skin refrigerant and age on pain responses of infants

receiving immunization. Research in nursing and health 1991;14(6):397-403.

12. Mavohedi Ali, Rosatomy, Salsali Mahvash, Moradi Ashin. Effects of local

refrigeration on venipuncture. 2006;10(2): 24-29.

13. Kuzu N, Ulcar H. The effects of cold on the occurrence of bruising,

hematoma and pain at the injection site in subcutaneous low molecular weight

heparin. Indian journal of nurses 2001;38(1):519.

14. Hasanpour M, Tootoonchi M, Aein F, Yadegarfar G. The effects of two non-

pharmacological pain management methods for intramuscular injection pain in

children. Acute pain 2006;8(1):7-12.

15. Weissaman SJ, Bernstein B, Schechter NL. Consequences of inadequate

analgesia during painful procedures in children. Archives of paediatric and

medicine 1998;152:147-49.

16. Yoon W, Chug S, Lee Y. Effect of ethyl chloride spray and ice cube for the

control of pain induced by the antibiotic skin test. American journal of

emergency Medicine 2006;26(1):59-61.

17. Yuka Saeki. Effect of cold or heat on the sensation of pricking pain based on

automatic response. Journal of nursing and heath science 2008;4(3):97-105.

18. Nestor S. Effect of spot cooling device on pain and discomfort. Clinical and

aesthetic dermatology 2010.

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19. Ebner CA. Cold therapy and its effect on procedural pain in children.

Comprehensive Paediatric Nursing 1996;19:197–208.

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9. Signature of the candidate
10. Remarks of the guide

11. Name and designation of (in block

letters)

11.1 Guide

HOD, CHILD HEALTH NURSING

SAHYADRI COLLEGE OF NURSING,

SAHYADRI CAMPUS, NH - 48 ADYAR,
MANGLORE- 575007.

11.2 Signature

11.3 Co-guide (if any)

11.4 Signature

1.5 Head of the department

HOD, CHILD HEALTH NURSING

SAHYADRI COLLEGE OF NURSING,

SAHYADRI CAMPUS, NH – 48, ADYAR,
MANGLORE- 575007.

11.6 Signature

12. 12.1 Remarks of the Principal

12.2 Signature

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