ORIGINAL RESEARCH ARTICLES: CERVIX AND HPV
Effects of Music Listening During Loop Electrosurgical Excision
Procedure on Pain and Anxiety: A Randomized Trial
Nopwaree Chantawong, MD and Kittipat Charoenkwan, MD, MSc
Objective: The aim of the study was to compare pain, anxiety, and satis-
faction between women, who listened to music, and those who did not
during loop electrosurgical excision procedure (LEEP).
Material and Methods: Participants were randomly assigned into two
groups. In group 1 (music), the participants listened to relaxing instrumental
music through the stereo headset from the time of arrival at the preoperative
waiting room until the procedure completed. For group 2 (control), the
participants underwent LEEP without music listening. The women rated
pain, anxiety, and satisfaction according to 10-cm visual analog scales.
Pain was assessed at the time of speculum insertion (baseline pain)
and immediately after the LEEP completed (procedural pain). Anxiety
and satisfaction were examined just before starting the LEEP and
10 minutes after the procedure completed.
Results: One hundred fifty patients (74 in music group and 76 in control
group) participated. Mean baseline pain scores after speculum insertion
were comparable between the groups (3.7 in the music group vs. 3.5 in the
control group, p = .55). Mean procedural pain scores were not different be-
tween the groups (4.7 in the music group vs. 5.2 in the control group,
p = .32). The differences of the procedural pain scores from baseline were sta-
tistically comparable between the study groups (0.9 in the music group vs.
1.7 in the control group, p = .15). There were no significant differences in
anxiety and satisfaction scores at any time points assessed between
the groups.
Conclusions: The effects of music listening on reducing pain and anxiety
during LEEP could not be demonstrated in this study.
Key Words: cervical dysplasia, large loop excision of transformation zone,
LEEP, loop electrosurgical excision procedure, music
(J Low Genit Tract Dis 2017;00: 00–00)
L oop electrosurgical excision procedure (LEEP) is the most
common therapeutic modality for intraepithelial neoplasia of
the cervix.1 Apart from its excellent therapeutic effectiveness,
LEEP also provides suitable specimens for definite histological
diagnosis.1–3 Although the incidence of procedure-related
complications is acceptably low, the pain during the procedure
is usually significant. Therefore, local anesthesia (in the forms
of intracervical injection, cervical spray, or cervical gel) or
paracervical block is generally required to reduce the pain asso-
ciated with the excision. This can be combined with the use of
nonsteroidal anti-inflammatory drugs to further lessen the
cramping pain resulted from reflex uterine contraction.4–7
However, in the recent randomized controlled trial conducted
by our group, the pain associated with electrosurgical excision
remained substantial even after the use of local anesthesia in
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology,
Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Correspondence to: Kittipat Charoenkwan, MD, Department of Obstetrics and
Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai
50200, Thailand. E-mail: kittipat.c@cmu.ac.th; charoenkwan@live.com
The authors have declared they have no conflicts of interest.
The study was supported by The National Research University Project under
Thailand's Office of the Higher Education Commission.
The institutional review board status was approved by the Faculty of Medicine,
Chiang Mai University Research Ethics Committee.
ClinicalTrials.gov Identifier: NCT02398916.
© 2017, American Society for Colposcopy and Cervical Pathology
DOI: 10.1097/LGT.0000000000000323
Journal of Lower Genital Tract Disease • Volume 00, Number 00, Month 2017
Copyright © 2017 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
recommended doses. The median pain rated by the participants
on a standard 10-cm visual analog scale from 0 (no pain) to 10
(worst possible pain) was 4.0 in the patients who had lidocaine
intracervical injection and 3.0 in those who received lidocaine
cervical spray.6
Moreover, receiving bad news regarding abnormal cervical
cytology result and having to go through subsequent procedures
including colposcopy, cervical biopsy, and LEEP can cause sig-
nificant anxiety and psychological distress. This is due most com-
monly to the fear of having cancer and the lack of clear knowledge
about the offered procedures.8–10
Interestingly, significant effects of music listening in reduc-
ing pain and anxiety associated with various minor procedures
in different disciplines have been demonstrated in many recent
reports. These study population included patients, who underwent
cystoscopy,11–13 colonoscopy,14 labor/vaginal delivery,15,16 col-
poscopy,17 mammography,18 and office hysteroscopy.19 However,
data on the similar effects of listening to music during LEEP are
lacking. The aim of this study was to compare pain, anxiety, and
satisfaction between women, who listened to music, and those
who did not during LEEP.
MATERIALS AND METHODS
Between March 2015 and March 2016, 150 women with any
degree of cervical intraepithelial neoplasia identified from cervi-
cal cytology and/or histology, who underwent LEEP in the outpa-
tient setting at our institution, were invited to participate in this
randomized controlled trial. Additional inclusion criteria were
18 years or older and an ability to communicate well in Thai.
Exclusion criteria comprised known history of hypersensitivity
to local anesthetics of the amide type or to other components of
the solution, pregnancy, history of neurologic deficit, drug abuse,
cervical or vaginal infection, and hearing disability. Informed
consent was obtained from each participant enrolled. Faculty
of Medicine Research Ethics Committee approved this study.
After enrollment, demographic, clinical, and operative data
including age, parity, medical comorbidities, cervical cytology re-
sults, colposcopic impression, and final histology (when avail-
able) were recorded. Upon arrival at the operating suite, the
participants were randomly assigned into two groups by a research
assistant, who opened sequentially numbered, opaque, sealed
envelopes containing study groups allocation. The envelopes
were opened sequentially and only after the envelope had been
irreversibly assigned to the participant. The random sequence
was generated by a computer. In group 1 (music), the participants
listened to relaxing modern western-style instrumental music
through the stereo headset provided, starting immediately after
randomization while they were in the preoperative waiting
area to the time of procedure completion. For group 2 (control),
the participants underwent LEEP without music listening
(see Figure 1).
Loop electrosurgical excision procedure was performed by
gynecologic oncology fellows in all cases. The approach to LEEP
was uniform, although varying loop sizes were selected to account
for variation in lesion dimensions. Each participant was placed in
lithotomy position, and the operative area was prepared using
sterile technique. Then, the cervix was examined through a
1
Chantawong and Charoenkwan Journal of Lower Genital Tract Disease • Volume 00, Number 00, Month 2017
FIGURE 1. Consort flow diagram.
sterile bivalve speculum. The operator chose a loop size based
on the dimension and contour of the cervix and the extent of the
cervical lesion identified at colposcopy. All patients were anes-
thetized with 4 puffs (40 mg, 10 mg/puff ) of 10% lidocaine
spray (10% Xylocaine spray; AstraZeneca AB, Södertälje,
Sweden) applied thoroughly to the ectocervix. The 3-minute
waiting time was allowed in all patients for the anesthetics to
take effect before carrying on with the excision. Then, the ex-
cision was carried out using blended cutting/coagulating mode.
After the excision, hemostasis was obtained by using the ball
electrode in coagulating mode with or without local application
of hemostatic agent. After the procedure, the patients were ob-
served for 30 minutes before being released home. Technique of
the electrosurgical loop pass during the excision, endocervical
curettage, and duration of the entire procedure were recorded.
The participants were asked to rate pain, anxiety, and satis-
faction according to 10-cm visual analog scales from 0 (no pain)
to 10 (worst possible pain). Pain was assessed at the time of spec-
ulum insertion (baseline pain) and immediately after the LEEP
completed (procedural pain). Anxiety and satisfaction were exam-
ined just before starting the procedure and 10 minutes after the
procedure completed. Primary outcome were procedural and base-
line pain scores. A 1-cm difference in visual analog scale scores
between the study groups was chosen as the smallest effect that
would be clinically significant. A sample size calculation was
based on the primary outcome. Considering SDs of each study
groups derived from our pilot study with the α value set at 0.05
and the power set at 80%, the sample size was calculated to be
75 patients for each group to detect a difference between the study
groups in procedural pain score of 1.
Statistical analysis was performed with Stata program Version
12 (StataCorp LP, College Station, TX). A plan was made to
compare continuous variables by using the two-tailed Student
t test. However, for continuous variables with skewed distribu-
tion, the Mann–Whitney U test was performed to compare the
2 © 2017, American Society for Colposcopy and Cervical Pathology
Copyright © 2017 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
median outcomes between the groups. The χ2 or Fisher exact
test, as considered appropriate, was used for comparison of cat-
egorical variables. All comparisons were made on an intention
to treat basis. Subgroup analysis based on colposcopic impres-
sion was performed. A p value of less than.05 was considered
statistically significant.
Role of the Funding Source
The funding source had no role in study design, data collec-
tion, data analysis, data interpretation, writing of the report, and
decision to submit this article for publication. The corresponding
author had final responsibility for the decision to submit
for publication.
RESULTS
One hundred fifty patients (74 in music group and 76 in con-
trol group) gave informed consent and were enrolled in this study
with no drop-outs. Demographic and clinical characteristics in-
cluding age, parity, and underlying medical conditions were com-
parable between the groups (see Table 1).
All pathological and operative characteristics were compara-
ble between the study groups (see Table 1). The presenting
cervical cytology was of low grade or less in nature in most
patients in both study groups, 58% in the music group, and
54% in the control group. At colposcopy, however, the findings
were suggestive of at least high-grade intraepithelial lesion in
more than 60% of the participants in the music group and in ap-
proximately 55% of those in the control group. In seven patients
(one in the music group and six in the control group), the colpos-
copy examination was considered unsatisfactory because of in-
complete visualization of the transformation zone. Moreover,
the final histological diagnosis of high-grade squamous intraepi-
thelial lesion (HSIL) or more was made in 77% and 74% of the
participants in the music and the control groups, respectively.
Journal of Lower Genital Tract Disease • Volume 00, Number 00, Month 2017 Music Listening During LEEP

measures to help alleviating the pain and anxiety associated with

TABLE 1. Participant Characteristics this procedure would be worthwhile.
Music listening may act as an emotional distraction leading
Characteristics Music (n = 74) Control (n = 76) p
to decreased pain sensation, fear of pain, and other related adverse
Age, y 46.5 (25 to 74) 44.0 (25 to 63) .42 experience.20,21 The role of distraction could be explained by
Parity 1.5 (0 to 7) 1.0 (0 to 3) .17 modulation of pain network in human brain. Valet et al.22 in a
Comorbidities 29 (39.2) 23 (30.3) .25 study based on functional magnetic resonance imaging of human
Cervical cytology .61 brain found that distraction resulted in reduction of pain-related
activation in multiple brain areas, especially in the area called me-
≤LSIL 43 (58.1) 41 (53.9)
dial pain system. Distraction also significantly increased the acti-
≥HSIL 31 (41.9) 35 (46.1) vation of the cingulo-frontal cortex, the periaqueductal gray, and
Colposcopic impression .15 the posterior thalamus.22 The type of music most commonly em-
≤LSIL 27 (36.5) 28 (36.8) ployed in practice has been relaxing music with continuous mel-
≥HSIL 46 (62.2) 42 (55.3) ody without strong rhythms, lyrics, and percussion. The lack of
Final histology .49 beneficial outcomes of music listening in this study may indicate
≤LSIL 16 (21.6) 20 (26.3) that the required distraction generated by the music listening had
≥HSIL 57 (77.0) 56 (73.7) not been achieved, and further technical exploration of the admin-
Technique of loop pass .51 istration of the music in this study would be necessary.
Single pass 51 (68.9) 55 (72.4) For one thing, the type of music selected by the investigators,
although consistent with the general recommendation for music
Double pass 23 (31.1) 20 (26.3)
use in health care settings, may not match with patients' prefer-
Triple pass 0 (0.0) 1 (1.3) ence. Mitchell et al.23 found that women who listened to person-
Procedure duration, min 10.0 (1.0 to 35.0) 10.0 (2.0 to 41.0) .56 ally preferred music tolerated pain significantly longer and rated
Data are expressed as n (%) or median (range). intensity of pain as significantly lower compared with those
LSIL indicates low-grade squamous intraepithelial lesion; HSIL, high-
listened to relaxation music and control group in a study that
grade squamous intraepithelial lesion. employed experimentally induced cold pressor pain. In studies
that the beneficial effects of music listening on pain and anx-
iety related to the studied procedures were demonstrated, both
Approximately, 70% of the participants in both groups had a participant-preferred12,15,16 and investigator-selected11,13,14,17
single pass excision technique. Endocervical curettage was music were employed. In an extensive review by Chi et al.,24 it
performed in all cases. The median operative duration was was suggested that a combination of both investigator-selected
10 minutes in both groups. and patient-preferred approach in music selection should be
Table 2 compares visual analog scale pain scores, anxiety employed. The primary selection of music should be based on
scores, and satisfaction scores at various stages of the LEEP pro- general recommendation as stated previously. As a result, a
cedure between the music and the control groups. Overall, mean collection of various styles of music could be created. Subse-
baseline pain scores after speculum insertion were comparable be- quently, patients can choose music from this collection based
tween the groups (3.7 in the music group vs. 3.5 in the control on personal preference.
group, 95% CI = −0.6 to 1.1, p = .55). Likewise, mean procedural For another thing, delivering music through the audio head-
pain scores were not different between the groups (4.7 in the music set can have drawbacks. It could prevent the participants from
group vs. 5.2 in the control group, 95% CI = −1.4 to 0.5, p = .32). normal recognition of the surroundings, which might actually
The differences of the procedural pain scores from baseline were raise the level of concern and anxiety and make them even
statistically comparable between the study groups (0.9 in the mu- more vulnerable to pain. These shortcomings could hinder the
sic group vs. 1.7 in the control group, 95% CI = −1.7 to 0.3, beneficial effect of music listening.
p = .15). There were no significant differences in anxiety and sat-
isfaction scores at any time points assessed between the groups.
TABLE 2. Main Outcomes

DISCUSSION 95% CI of
difference between
After the use of a lidocaine spray, procedural pain from
Characteristics Music Control the groups p
LEEP is moderate and is not further reduced with the music inter-
vention we employed. In this study, the pain associated with elec- Pain scores
trosurgical excision of the cervix was 4.7 in the music group and Baseline 3.7 (2.6) 3.5 (2.4) −0.6 to 1.1 .55
5.2 in the control group with the use of standard local anesthesia. Procedural 4.7 (2.9) 5.2 (2.9) −1.4 to 0.5 .32
This was consistent with the findings from our previous study Pain score difference 0.9 (3.2) 1.7 (2.8) −1.7 to 0.3 .15
comparing xylocaine injection and xylocaine spray as local anes- from baseline
thetic technique during LEEP, in which the median excision pain (procedural-baseline)
score was 4.0 in the injection group and 3.0 in the spray group.6 Anxiety scores
Similarly, in the prospective clinical trial by Harper et al.4 compar- Before procedure 3.7 (2.6) 4.1 (3.0) −1.3 to 0.5 .38
ing distal paracervical block and intramucosal block during LEEP, After procedure 4.0 (2.9) 4.7 (3.2) −1.7 to 0.3 .16
the median Likert scale pain scores were 3 for the paracervical
Satisfaction scores
block group and 4 for those with intramucosal block after nonste-
roidal anti-inflammatory drugs premedication. Apart from pain, Before procedure 6.5 (2.9) 7.3 (2.3) −1.7 to 0.02 .06
considerable level of anxiety was evident in both groups of our After procedure 8.3 (1.8) 7.8 (2.1) −0.2 to 1.1 .15
study participants with visual analog scores ranging from approx- Data are expressed as mean (SD).
imately 3.7 to 4.7. These findings have indicated that additional

© 2017, American Society for Colposcopy and Cervical Pathology 3

Copyright © 2017 American Society for Colposcopy and Cervical Pathology. Unauthorized reproduction of this article is prohibited.
Chantawong and Charoenkwan Journal of Lower Genital Tract Disease • Volume 00, Number 00, Month 2017
The strength of this study included the prospective random-
ized controlled design with adequate allocation concealment.
The procedure was performed by operators of the same level of
experience. There was no protocol deviation, and all participants
consistently received assigned intervention without interruption.
All participants provided main outcome data for final analysis
according to the assigned study groups.
The limitations of this study included the inability to blind
the participants and the operators due to the nature of the investi-
gation. With subjective outcomes such as pain, anxiety, and satis-
faction, this could result in information bias (reporting bias). In
addition, the sample size of the present study may not be large
enough to detect small difference in outcome of interest. Although
the 95% CI of the difference in procedural pain scores between the
groups appeared rather narrow (−1.4 to 0.5) suggesting an accept-
able precision of the hypothesis test, the difference could possibly
be as high as 1.4 in favor of music listening in a repeated study. In
this study, the sample size calculation was performed with an aim
to provide an adequate sample size to detect the 1-cm difference in
visual analog scale procedural pain scores between the study
groups. Although considerable body of research has found that
the visual analog scale for pain carries strong construct validity
and reliability, a clinically significant difference in experimental
or clinical pain outcome is nearly universally considered to be
33% or more.25,26 Therefore, defining a clinically significant dif-
ference as “1 cm” of “10 cm” on visual analog scale might not be
considered appropriate in most clinical pain studies.
In conclusion, the significant effects of music listening in re-
ducing pain and anxiety during LEEP could not be demonstrated
in this study. Further larger investigation with different approach
in music selection and music administration would be worthwhile.
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