Impact of Relaxation Training on Patient-Perceived

Measures of Anxiety, Pain, and Outcomes after

Interventional Electrophysiology Procedures
ANTREAS HINDOYAN, M.D., MICHAEL CAO, M.D., DAVID A. CESARIO, M.D. PH.D.,
JEROLD S. SHINBANE, M.D., and LESLIE A. SAXON, M.D.
From the Keck School of Medicine, University of Southern California, Los Angeles, California

Background: Electrophysiology procedures vary in invasiveness, duration, and anesthesia utilized.

While complications are low and efficacy high, cases are elective and patient experiences related to
anxiety, pain, and perceived outcomes are not well studied. We sought to determine if a 30-minute
audio compact disc (CD) that teaches relaxation techniques and wellness perception prior to an elective
procedure impacts validated measures of anxiety, pain, and procedural outcomes.
Methods: Sixty-one patients were randomly assigned to a control group (CG) (NCG = 31) or interventional
group (IG) (NIG = 30). Both groups answered a baseline Hospital Anxiety and Depression Scale (HADS-
A) survey consisting only of anxiety assessment questions. The IG listened to the CD the night prior to
their procedure. Heart rate and blood pressure were monitored on admission and prior to the procedure.
Postprocedure, both groups completed two HADS-A surveys as well as two Patient Experience Surveys
(PES). There was no statistical difference in the demographics and the rate of procedural complications
between the groups. The statistical significance of our data was determined using a Students t-test and
2 test.
Results: At baseline, both groups had equal amounts of anxiety prior to their procedures (P = 0.2). The
patients in the IG had lower systolic blood pressures during admission and prior the administration of
analgesics in comparison to the CG. Postprocedure, results from administering the HADS-A demonstrated
that the IG had 33% lower anxiety (P = 0.02) than CG patients.
Conclusion: The implementation of basic relaxation teaching techniques prior to planned
electrophysiology procedures lowers systolic blood pressure and postprocedural anxiety. (PACE 2011: 34:
821826)
outcomes, quality of care, invasive electrophysiology, anxiety

Introduction and face a higher risk of mortality.2 Furthermore,

Preoperative anxiety is prevalent in over 55%
of patients scheduled to undergo an elective
invasive cardiac procedure.1 It has been shown
that patients who do experience symptoms of
depression and anxiety after an adverse cardiac
event such as a myocardial infarction are more
likely to experience a recurrent cardiac event
Disclosures:
Antreas Hindoyan: None
Michael Cao: Consultant to Boston Scientific Corporation.
David Cesario: Consultant to Boston Scientific Corporation and
Medtronic, Inc.
Leslie Saxon: Consultant to Boston Scientific Corporation and
Medtronic, Inc.
Address for reprints: Leslie A. Saxon, M.D., Keck School of
Medicine, University of Southern California, 1510 San Pablo
Street, Suite 322, Los Angeles, CA 90033. Fax: 323-442-6133;
e-mail: saxon@usc.edu
Received June 30, 2010; revised February 9, 2011; accepted
February 9, 2011.
doi: 10.1111/j.1540-8159.2011.03119.x
individuals who are hospitalized due to a cardiac
event with elevated levels of anxiety experience
an increased rate of early and late complications
during their hospitalizations, independent of
demographic variables or medical history.3
Although the relationship between preproce-
dural stress reduction and invasive cardiovascular
procedures such as cardiac catheterization, coro-
nary artery bypass grafting (CABG), and peripheral
vascular angiography have been examined, there
exists a paucity of studies examining how preop-
erative interventions affect measures of anxiety,
pain, and patient perceptions in a population
undergoing a diverse range of electrophysiology
(EP) procedures.47 These procedures are usually
elective and vary in invasiveness, duration, and
anesthetics utilized.
Most medical centers rely on traditional meth-
ods to control pain and anxiety, utilizing sedatives
and analgesics as signs and symptoms arise. We
sought to determine if in addition to providing
these standards of care, educating patients with
a 30-minute audio compact disc (CD) comprised

C 2011, The Authors. Journal compilation 

 C 2011 Wiley Periodicals, Inc.

PACE, Vol. 34 July 2011 821

 HINDOYAN, ET AL.
of relaxation exercises and wellness perception
education impacts validated measures of anxiety,
pain, and adverse outcomes. The CD utilized in
the study was developed by Michelle Leclaire
ONeill, Ph.D., R.N., a psychoneuroimmunologist
who has over 10 years of experience in counseling
patients on meditation, imagery, and the process
of death and dying at the Simonton Cancer Center
in Southern California. The content of the CD was
designed to encourage patient relaxation through
self-awareness, acknowledgment, and mitigation
of all personal stressors. Set to a serene melody,
a narrator describes stretching exercises and
meditation techniques to achieve a state where
an individual, fully cognizant of their mental
and physical being, can explore a disposition
were all bodily systems perform optimally. It was
identified by University of Southern California
EP faculty as a potentially useful instrument for
reducing pre- and postprocedural anxiety.
Methods
The study group consisted of 61 consecutive
patients who were scheduled to undergo an
elective EP procedure between August 2007 and
November 2008 at the University of Southern
California University Hospitals. Scheduled pro-
cedures included EP studies with and with-
out ablations, device implantations/replacements,
and transesophageal echocardiograms with car-
dioversions. The study was carried out under
institutional protocol no. HS 0700053. Eligibility
criteria included the ability to communicate pro-
ficiently in English. Patients were randomized to
a control group (CG) or an intervention group (IG)
using random binary number generation. No other
variables were used to further stratify individual
assignments. Patients in the IG were supplied the
30-minute CD that provided instructions in basic
relaxation techniques and were instructed to listen
to it in its entirety the night prior to the planned
procedure. All individuals had their respective
procedures within a month from enrollment, with
a vast majority completing all study requirements
within 1 week.
Both groups completed a survey consisting
of questions pertaining only to anxiety from the
well-validated Hospital Anxiety and Depression
Scale (HADS-A).8,9 Baseline HADS-A data were
collected at the time of enrollment. Postinterven-
tion surveys were administered at 2 and 5 days
after a procedure. The HADS-A survey has been
shown to have validity and accuracy in assessing
the severity of anxiety in hospitalized and general
population patients. A score of 8 or greater has
been identified as a marker for significant anxiety
with an excellent sensitivity and specificity (0.9
and 0.8, respectively).10
822 July 2011
In order to further validate subjective mea-
sures of anxiety and apprehension, quantifiable
measures, such as heart rate and blood pressure,
were recorded to assess a patients sympathetic
response.1113
Patients were also administered a standard-
ized Patient Experience Survey (PES) on days 2
and 5 postprocedure. The PES was modified from
a questionnaire used by Kim et al. to measure
preprocedural anxiety, difficulty of preprocedural
preparation, perceived pain during and after the
procedure, overall satisfaction, and willingness
to repeat the procedure if recommended by the
attending physician.14 The survey used a Likert
scale to quantify responses. In addition to the orig-
inal questionnaire, a question was added to assess
the patients procedural comprehension (Table I).
After the completion of a procedure, the
physicians procedure report, discharge summary,
and first postdischarge clinic notes were reviewed.
Outcome data from each intervention were
compiled and analyzed. Adverse outcomes or
complications with the hospitalization or the
procedure were categorized as being major or
minor. A major complication was defined as a
significant, unforeseen outcome directly related
to the planned intervention, which required an
additional procedure to remedy the problem.
A minor complication was any unanticipated
event related to the patients hospitalization
that required further diagnosis or treatment.
The purpose of collecting this data was to
account for unpredictable events that may have
disproportionally affected measured subjective
and objective variables in one subset of the study
population.
All procedures were performed at the two
main teaching hospitals of the University of
Southern California, Keck School of Medicine.
All patients underwent standard preprocedural
education consisting of a consultation with a
trained EP nurse and an attending physician
regarding the invasive procedure, its therapeutic
effect, and the risks and benefits associated with
the procedure. In addition, patients were provided
written materials that described the procedure and
provided with a link to the USC Cardiovascular
Medicine website where additional information is
available.15
Analysis
The analysis of the HADS-A survey comprised
the summing of the total score of each survey.
Each patient was administered three HADS-
A surveys (one preprocedure [HADS-A1] and
two postprocedure [HADS-A2 and HADS-A3]).
Although two postprocedure surveys were taken
as written in the protocol of the study, the short
PACE, Vol. 34
 RELAXATION AFTER INTERVENTIONAL ELECTROPHYSIOLOGY PROCEDURES

Table I. Table II.

Patient Experience Survey (PES) Patient Demographics

1. How worried were you before the procedure? Control Intervention

1 2 3 4 5 N = 61 N = 31 N = 30 P-value
Not worried Extremely worried
2. How difficult was the preparation for the procedure? Age SE (years) 52 20 55 20 0.3
1 2 3 4 5 Sex (% male) 61 60 0.5
Not difficult Extremely difficult Primary language 94 90 0.2
3. How well did you understand the procedure? (% English)
1 2 3 4 5 Diabetes mellitus (%) 26 13 0.2
Very well Not at all Coronary artery 32 28 0.3
disease (%)
4. How uncomfortable was the test overall? Mean LVEF (% SE) 44 18 46 17 0.4
1 2 3 4 5 % Hospitalized in past 48 34 0.2
Comfortable Uncomfortable 6 months
5. How respected (dignified) did you feel during the Previous cardiac 68 57 0.2
procedure? procedure (%)
1 2 3 4 5 Duration of CVD 45 46 86 135 0.08
Respect Not respected (months SE)
6. How much pain were you in during the procedure? -blocker use (%) 64 44 0.08
1 2 3 4 5
Non Severe CVD = cardiovascular disease; SE = standard error of mean.
7. If you received pain medication during the procedure,
do you feel you were given enough?
and CG were calculated, and the Students t-test
1 2 3 4 5
was used to determine the statistical significance
Enough Not enough
of the results. A P-value 0.05 was set as the
8. How much pain were you in after the procedure? threshold for achieving statistical significance in
1 2 3 4 5 all calculations for this study.
None Severe PES results were analyzed on a per question
9. If you received pain medication after the procedure, do basis for each survey. The number of responses
you feel you were given enough? for each numerical value was tallied for all
1 2 3 4 5 individuals in the IG and CG, respectively.
Enough Not enough Expected values were also calculated for each
10. Do you feel that there were any complications with response and compared to actual results using a
the procedure? 2 test with 4 degrees of freedom. P-values were
1 2 3 4 5 calculated based on the 2 values.
None Major The blood pressure and pulse of each
individual were taken on admission and prior
11. How satisfied were you with the procedure overall? to commencement of the procedure. Blood pres-
1 2 3 4 5 sure measurements were divided into systolic,
Very satisfied Dissatisfied diastolic, and mean blood pressure, respectively.
12. If it were advised by your doctor, how willing would Values for all individuals were averaged and a
you be to undergo this procedure again? standard deviation was calculated for each group.
1 2 3 4 5 A Students t-test was used to determine the
Very willing Not willing statistical significance of the results between the
two groups.

temporal relationship between the two surveys Results

taken did not allow sufficient time to establish a
trajectory of anxiety levels as patients got further
out from their respective procedures; thus, only
HADS-A2 was included in the analysis of the
study. Scores for each individual were divided
based on the randomization assignments. For each
survey, the mean and standard deviation for the IG
Patient demographics are shown in Table II.
There were no significant differences between
randomized patients with regard to the demo-
graphic factors surveyed. The average age of the
61 subjects was 53 20 (range 1688 years).
The majority of subjects were male, who had
been diagnosed with a cardiac condition multiple

PACE, Vol. 34 July 2011 823

 HINDOYAN, ET AL.

Table III. The analysis of the PES demonstrated that

patients randomized to the IG reported less pain,
History of Previous Cardiac Procedures had fewer operative complications, and felt more
satisfied with the experience as a whole than
Control Interventional the CG subjects; however, no individual question
Group Group achieved statistical significance secondary to the
fact that our study lacked significant power.
CABG 4 2 Patients in the IG had a clear trend toward
Congenital heart surgery 3 1 a lower heart rate and mean blood pressure on
Device implant 4 4 admission and prior to the procedure, compared
Cardiac catheterization 4 7 to the CG. However, this did not reach statistical
Valvular surgery 1 0 significance (pHR, adm. = 0.9, pHR, on table = 0.6 and
EPS with or without ablation 0 5 pMAP, adm. = 0.08, pMAP, on table = 0.1, respectively).
TEE with cardioversion 0 5 When systolic blood pressure (SBP) was evaluated
Other cardiac surgery 1 1 as a single variable, it was found to be significantly
Totals 17 25 different between the two groups. Prior to
the initiation of any intervention, before the
CABG = coronary artery bypass graft; EPS = electrophysiology administration of any analgesics or sedatives, the
study; TEE = transesophageal echocardiography. IGs systolic blood pressure (SBP) was 12 mmHg
lower than the CGs (P = 0.03, Tables V and
VI, Figs. 2 and 3). In addition, the IGs SBP was
months prior to enrollment. Greater than 40% 12 mmHg lower on admission compared to the
of those surveyed reported a hospitalization in CGs (P = 0.04).
the past 6 months and 62% reported having had Immediate procedural outcomes data demon-
a previous cardiac procedure, including surgery strate that the rates of both major and minor
for congenital heart disease, coronary bypass complications were not statistically different
grafting, valvular replacement, cardiac catheter- between the two groups (IGMajor 0.07, CGMajor 0.03,
ization, device implantation, transthoracic echo pMajor = 0.4, IGMinor 0.3, CGMinor 0.2, PMinor = 0.3).
with cardioversion, and EP studies with and
without ablation. However, a greater proportion
of individuals in the IG had undergone multiple Discussion
procedures as compared to the CG prior to the The number of EP procedures performed in
enrollment in our study (Table III). the United States is increasing with nearly 3 mil-
HADS-A survey scores obtained during pre- lion implantable devices placed between 1990 and
and postprocedure are shown in Table IV. Prior 2002.16 Between 1997 and 2004, there was a 60%
to the procedure, anxiety scores did not differ increase in the number of implantable cardioverter
between the two groups (P = 0.2). The scores for defibrillators implanted and a 19% increase in the
each group had a standard deviation greater than 8, number of pacemaker implants.17 There are greater
indicating individuals in both groups experienced than 20,000 ablations performed yearly as well as
significant preprocedural anxiety (Fig. 1A). The a countless number of cardioversions.18 There is
IG had significantly lower HADS-A survey scores a broad spectrum of EP procedures, each varying
with standard deviations under the threshold of 8 in invasiveness, duration, and involving a diverse
on HADS-A2 (P = 0.02, Fig. 1B). patient population ranging from the very young to
the elderly, and they tend to be a source of anxiety,
mental fatigue, and pain for patients.1921
Table IV.
Our single-center study supports that indi-
viduals, regardless of previous interventions and
HADS-A Surveys preprocedural education, experience a significant
amount of anxiety and apprehension prior to an EP
Survey 2 procedure. The decrease in HADS-A survey scores
(Immediately in both groups following their respective proce-
Survey 1 Postintervention dures, demonstrated by the postprocedure HADS-
(Prior to CD) and CD) A survey, illustrates that patients experience some
relief after the completion of their respective pro-
Intervention (N = 30) 5.6 4.3 3.9 3.6 cedure. However, the IGs postprocedural anxiety
Control (N = 31) 6.5 4.1 5.9 4.9 scores and significantly lower SBP suggest that
P-value 0.2 .02 the integration of simple relaxation techniques
prior to an invasive procedure provides significant

824 July 2011 PACE, Vol. 34

 RELAXATION AFTER INTERVENTIONAL ELECTROPHYSIOLOGY PROCEDURES

Figure 1. HADS-A surveys.

mental comfort prior to and immediately after the each study patients encounter, the heterogeneous
occurrence. procedure pool, varying amounts of analgesics
Furthermore, the lack of difference between used, previous procedural experiences, previous
the rate of both major and minor adverse outcomes practice of meditation and stress management
amongst the two groups only enhances the validity techniques, use of -blockers, and individual
of our findings. It demonstrates that no one group
was subjected to a greater degree of unforeseen
circumstances that could have disproportionately
biased responses to subjective questions and
potentially confounded the impact of the inter-
vention. However, despite efforts to standardize

Table V.
Average Pulse, Systolic Blood Pressure, and Diastolic
Blood Pressure

Pulse SBP DBP

Admission BPM mmHg mmHg

Control 75 13 130 18 74 12 Figure 2. Systolic blood pressure on admission.

Intervention 75 13 118 18 68 12
P-value 0.63 0.04 0.14

Table VI.
Average Pulse, Systolic Blood Pressure, and Diastolic
Blood Pressure Prior to the Procedure

Pulse SBP DBP

On Table BPM mmHg mmHg

Control 73 16 134 20 72 14
Intervention 76 18 122 18 68 12
P-value 0.63 0.03 0.4
Figure 3. Systolic blood pressure prior to the procedure.

PACE, Vol. 34 July 2011 825

 HINDOYAN, ET AL.
physicians techniques were all variables that were
not controlled for in our study. Although each
of these factors may have had a minimal but
not arbitrary effect on individual outcomes, it
likely did not significantly bias the results of the
study.
Although any invasive procedure evokes
uneasiness, it is clear that postprocedural anxiety
and qualitative assessments are improved by
augmenting standard patient education with an
inexpensive tool illustrating stress management
techniques, such as our CD, to address patients
reservations.22,23 As we dawn upon a new era
of more personalized patient care, the national
push to innovate clinical tools that champion in-
dividualized treatment paradigms are paramount.
The relaxation training on the CD that was added
to standard patient education was found to be
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PACE, Vol. 34
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