Pediatr Surg Int (2015) 31:197201
DOI 10.1007/s00383-014-3649-9
ORIGINAL ARTICLE
The effect of audio therapy to treat postoperative pain in children
undergoing major surgery: a randomized controlled trial
B. S. Sunitha Suresh Gildasio S. De Oliveira Jr.
Santhanam Suresh
Accepted: 3 December 2014 / Published online: 3 January 2015
Springer-Verlag Berlin Heidelberg 2015
Abstract
Purpose To evaluate the analgesic effect of music and
audiobooks in children undergoing major surgical proce-
dures when compared to a control (silence) group.
Methods The study was a prospective and randomized
trial. Children undergoing major surgeries were random-
ized to one of the three groups: music, audiobook or con-
trol (silence). The primary outcome was the pain burden
reduction by two treatments within 48 h postoperatively.
Pain burden was measured using the area under the pain
scale versus the 30 min interval for each treatment.
Results 60 patients were recruited and 56 completed the
study. Pain burden was reduced in the music and audio-
book groups compared to control, median (IQR) of -60
(-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (min 9 pain
score), respectively, P = 0.04. A linear regression analysis
demonstrated an independent group effect on pain reduc-
tion even after adjusting for the mean pain scores recorded
at the beginning of the treatment, slope of regression line
-56.8 24 goodness of fit r2 = 0.25 and slope signifi-
cantly different from 0 (P = 0.02).
Conclusions Audio therapy is an efficacious adjunct
method to decrease post-surgical pain in children
B. S. Sunitha Suresh
G. S. De Oliveira Jr.
S. Suresh
Department of Pediatric Anesthesiology, Ann & Robert H. Lurie
Childrens Hospital of Chicago, Chicago, IL, USA
Present Address:
B. S. Sunitha Suresh
Johns Hopkins Medical School, Baltimore, MD, USA
G. S. De Oliveira Jr. (&)
Department of Anesthesiology, Northwestern University,
241 East Huron St F5-704, Chicago, IL, USA
e-mail: g-jr@northwestern.edu
undergoing major surgeries. Audio therapy should be
considered as an important strategy to minimize pain in
children undergoing major surgery.
Keywords Music post-surgical pain
Music treatment
pain surgery children
Introduction
The treatment of post-surgical pain in children often relies
on the use of opioid analgesics [1, 2]. Due to the fear of
opioid-related side effects such as respiratory depression,
caregivers usually limit the amount of opioids given to
children and this practice frequently results in poor post-
surgical analgesic control [35]. In addition, the use of
non-opioid drugs for pain control in children is commonly
hindered by the lack of studies addressing efficacy and
safety of those drugs in this patient population [6, 7].
The use of non-pharmacological therapies such as music
has been evaluated with promising results to minimize pain
in children [8]. Nevertheless, prior studies focused pri-
marily in the use of music therapy to minimize pain
associated with short medical procedures such as veni-
puncture but not for the treatment of post-surgical pain
[911]. The distracting and anxiolytic properties of au-
diobooks may also have a promising effect on pain control
in children undergoing surgery but their efficacy remains to
be evaluated [12]. Currently, there is a lack of recom-
mendation for non-pharmacological strategies by practice
guidelines for the treatment of post-surgical pain in chil-
dren [13].
The main objective of the current investigation was to
evaluate the potential analgesic effect of music and au-
diobooks in children undergoing major surgical procedures
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when compared to a control (silence) group. We hypoth-
esized that children exposed to music or audiobooks during
the post-surgical period would have less pain than children
in the control group.
Materials and methods
This was a prospective, randomized and controlled study.
The study was approved by the Ann & Robert H. Lurie
Childrens Hospitals Institutional Review Board. Written
informed consent was obtained from the guardians of all
patients and assent was also obtained from children older
than 8 years of age. Children aged from 6 to 18 years
scheduled for major elective orthopedic, neurosurgical,
urological, plastic or general surgeries at Lurie Childrens
Hospital of Chicago, USA were recruited to participate in
this study. Children were excluded if they were hearing
impaired, mentally challenged and if they had chronic pain
or opioids use.
Patients were randomized using a computer-generated
table of random numbers to three groups: a music, an au-
diobook and a silence control group. Allocation was con-
cealed by keeping the allocated treatment group in a sealed
opaque envelope that was opened only after the child
entered the study. Prior to surgery, if the patients were
allocated to the music or the audiobook group, they were
provided a playlist for music and a set of audiobooks to
choose from. This allowed them to make their choice prior
to any effects of anesthesia or surgery. The Audiobook
group wore noise-canceling headphones (Etymotics; Elk
Grove Village, IL, USA) connected to an iPodTM (Apple
Incorporated; Cupertino, CA, USA) containing a selection
of audiobooks and listened to an audiobook of their choice
for 30 min. For the Music Group, a playlist from selections
provided on an iPodTM was created. Children wore noise-
canceling headphones and listened to their music for
30 min. The Silence control group received no
intervention.
The Faces Pain Scale-Revised FPS-R, a validated scale
to assess pain in children of 4 or 5 years old, was used to
evaluate pain. Pain scores were assessed before treatment
and 30 min after treatment within 48 h after surgery. The
difference between post and pre-treatment pain scores was
calculated as the main treatment effect for the study. This
method accounted for differences in pain intensity among
distinct surgeries and differences in analgesic treatments.
The primary outcome was the pain burden reduction by the
two treatments. Pain burden reduction was measured by the
decrement in the area under the pain scale versus the
30 min time curve for each treatment using the trapezoidal
method (Graph Pad Prism version 5.03, Graph Pad Soft-
ware, Inc., La Jolla, Ca) [14]. For all children, pain was
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Pediatr Surg Int (2015) 31:197201
treated according to the standard of the institution and
adapted to the specific type of surgery and age. Other data
collected included age, gender, surgical type and duration
of surgery. All data were collected by a single investigator
(SS).
In a one-way ANOVA study, sample sizes of 18, 18 and
18 will be obtained from the three groups whose means are
to be compared. The total sample size of 54 subjects
achieves 82 % power to detect differences with an effect
size of 1 point difference in pain scores between groups
and using a F test with a 0.01 significance level. The size of
variation in the means is represented by their standard
deviation which is 0.82. The common standard deviation
within a group is assumed to be 1.5. 20 patients per group
were recruited to account for possible drop outs. Power
calculation was performed using PASS version 8.0.15,
2010 (NCSS, LLC, Kaysville, UT).
The ShapiroWilk and KolmogorovSmirnov tests were
used to test the hypothesis of normal distribution. Nor-
mally, distributed interval data are reported as mean (SD)
and were evaluated by one-way ANOVA. Non-normally
distributed interval data and ordinal data are reported as
median [interquartile range (IRQ)] using the Kruskal
Wallis H test. Post-hoc comparisons were made using the
TukeyKramer or Dunns test with Bonferroni correction
for multiple comparisons [15]. Categorical variables were
evaluated using the Fishers exact test. An additional
exploratory analysis was performed by combing the au-
diobook and music groups (audio therapy) and median
differences and 95 % confidence intervals of the differ-
ences in pain burden reduction were calculated using a
10,000 sample bootstrapping method. All reported P values
are two tailed. A generalized linear regression model was
also conducted to control for the treatment effect across
different initial pain scores. Statistical analysis was per-
formed using Stata version 12 (StataCorporation 2011.
Stata Statistical Software: Release 12; College Station,
TX: StataCorp LP.)
Results
Sixty children undergoing major surgery were recruited to
the study between July 2010 and December 2010. The
details of the conduct of the study are presented in Fig. 1.
Six patients were excluded from the final analysis. Three
patients were discharged home before receiving the two
interventions and three patients requested to be excluded
from the study. There were no differences on baseline
characteristics among the study groups (Table 1). The
median (IQR) for time to the first treatment was 18.7
(17.520.2), 17.2 (1623) and 18.1 (1621.7) h for the
music, audiobook and control, respectively, P = 0.96. The
Pediatr Surg Int (2015) 31:197201 199

Fig. 1 Consort flow diagram

for the study

Table 1 Baseline Music (n = 18) Audiobook (n = 17) Control (n = 19) P value

characteristics of the study
groups Age (years) 10.9 (9.113.9) 12.9 (11.513.9) 12.4 (9.814.6) 0.55
Gender 0.53
Male 8 6 10
Female 10 11 9
Type of surgery 0.65
Orthopedics 3 2 2
General surgery 5 6 5
Urology 0 1 0
Thoracic 3 0 4
Neurological 7 8 7
Vascular 0 0 1
Surgical duration (min) 174 (144315) 245 (143439) 215 (139384) 0.65
Type of post-surgical analgesia 0.38
IV PCA opioids 7 9 7
IV opioids 4 4 6
Epidural 4 4 2
Non-opioid analgesics 3 0 4

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Fig. 2 Box plots demonstrating greater reduction in pain burden in
the audio therapy patients compared to control. Data were analyzed
using the MannWhitney U test (P \ 0.05). Min 9 pain
score = minutes multiplied by pain scores (010 scale). The limits
of the box plots denote 25 and 75 % quartiles. Dots outside whiskers
represent outliers
median (IQR) for the time to the second treatment was 23
(21.525.7), 24 (2042.2) and 22.7 (19.724.5) h for the
music, audiobook and control, respectively, P = 0.56.
Pain burden was reduced in the music and audiobook
groups compared to control, median (IQR) of -60 (-90 to
0), -45 (-90 to 0) and 0 (-30 to 90) (60 min 9 pain
score), respectively, P = 0.04. A pairwise comparison
between the music and the control group did not achieve
statistical significance after correcting for multiple com-
parisons (P = 0.055). We found that two patients in the
audiobook, four in the music and three in control group
received analgesic medications during the intervention,
which demonstrated a balanced effect of potential con-
founders (P = 0.9).
An exploratory analysis of audio therapy (music or au-
diobooks) compared to control group demonstrated a
reduced pain burden in the audio therapy group compared
to control, median (IQR) of -60 (-90 to 0) and 0 (-30 to
90), respectively, P = 0.01 (Fig. 2). A generalized linear
regression analysis demonstrated an independent group
effect on pain reduction even after adjusting for the mean
pain scores recorded at the beginning of the treatment,
slope of regression line -56.8 24 goodness of fit
r2 = 0.25 and slope significantly different from 0
(P = 0.02).
Discussion
The most important finding of the current investigation was
the reduction in post-surgical pain in children exposed to
music or audiobooks compared to control after major sur-
gery. The reduction in pain burden was one point (010
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Pediatr Surg Int (2015) 31:197201
scale) over 1 h of total treatment that the audio therapy
groups received compared to control. Our results suggest
that audio therapy should be available to minimize post-
surgical pain in children undergoing major surgeries.
Our findings are clinically important because audio
therapy is not currently implemented to reduce post-sur-
gical pain in children undergoing major surgeries. In
addition, practice guidelines for post-surgical pain control
in children do not recommend the use of audio therapy as a
method of analgesia control in children. To the best of our
knowledge, this is the first randomized study to evaluate
and demonstrate the use of patient-preferred audio therapy
as promising non-pharmacological strategy to control post-
surgical pain in children.
Another important finding of the current investigation
was the detection of an effect in the audio therapy groups to
minimize post-surgical pain irrespective of the baseline
pain score. This fact suggests that audio therapy may not
only be effective as an adjunct for major surgeries but also
to less painful procedures performed in the ambulatory
setting [16, 17]. Ambulatory patients cannot rely on potent
and rapid acting intravenous drugs to minimize pain [18].
After children are discharged home from the ambulatory
surgical unit, parents can continue to use audio therapy to
reduce post-surgical pain.
We did not detect a difference in the analgesic effect of
music compared to audiobooks in the current study. It is
possible that the distracting and anxiety relieving effect of
an audio therapy may be responsible for the reduction in
post-surgical pain regardless of the audio method utilized.
Children can likely chose between the two methods
according to their preference without significant detriment
in the post-surgical pain control. Since anxiety and pain are
often related, future studies to examine the efficacy of
audio therapy on post-surgical pain should also include an
anxiety assessment [19].
In contrast to opioid analgesics, the lack of side effects
of audio therapy seems to pave a promising pathway for the
implementation of this intervention for children undergo-
ing major surgeries. We believe that costs associated with
the audio intervention should not be considered a major
barrier to implement the audio interventions to minimize
pain in children undergoing major surgery. Improvement in
analgesic control after surgery has been associated with
improvements in important economic outcomes in the adult
population such as reduction of hospital length of stay or
unanticipated hospital readmission after surgery [20, 21].
We observed beneficial effects of audio therapy even in
some patients who received epidural analgesia. It is pos-
sible that the pain reduction effect of audio therapy in those
patients was mediated by a reduction in post-surgical
anxiety [22, 23]. Unfortunately, we did not concomitantly
measured anxiety as part of our study outcomes. Future
Pediatr Surg Int (2015) 31:197201
studies evaluating the effect of audio therapy on acute post-
surgical pain should include a validated anxiety measure-
ment as one of their outcomes.
Our study should only be interpreted in the context of its
limitations. We did not control for parent personality
characteristics that could have affected childrens pain and
anxiety [24]. However; since subjects were randomized, we
expected that those differences would be evenly distributed
among the study groups. Due to the nature of our inter-
vention, we were not able to blind patients and observers.
Lastly, we did not include children younger than 6 years of
age and our findings of the current study remain to be
extended to that age group.
In summary, we demonstrated for the first time that
audio therapy is an efficacious adjunct method to decrease
post-surgical pain in children undergoing major surgeries.
The type of audio therapy (music or audiobooks) does not
seem to lead to significant clinical reduction in post-sur-
gical pain. Due to the lack of side effects, audio therapy
should be considered by hospitals and clinical practitioners
as an important strategy to minimize pain in children
undergoing major surgery.
Acknowledgments The authors would like to thank Music Theory
and Cognition Professor Richard Ashley, Northwestern University,
Evanston, Illinois for his support of the study. Ann & Robert H. Lurie
Childrens Hospital of Chicago; Northwestern University.
Conflict of interest None.
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