Previous studies have shown that using music as a non-pharmacological intervention is an
effective, safe, and inexpensive way to address pain and anxiety in patients during
cystoscopies. However few studies have compared patient outcomes between preferred music and
classical music groups, and no studies have compared these groups in a North American sample
population. The intent of this project is to compare pain and anxiety in those listening to
their preferred music, classical music, and no music during their cystoscopy to assess what
might be the optimal way to provide this non-pharmacological intervention. Identifying and
understanding non-pharmacological interventions that can reduce pain and anxiety during
cystoscopies is an important task that will allow urologists to better manage these patients.
The purpose of this study is to assess the impact of a patient's preferred choice of music on
pain and anxiety when compared to classical music and the absence of music.
The study design will included a 1:1:1 randomization with equal group membership performed
for both male and female sexes. Group 1 will allow patients to listen to their preferred
music choice during cystoscopy, group 2 will listen to a standardized copyright free playlist
of classical music, and group 3 will listen to no music and serve as a control group.
Patients will be recruited and consented on the day of the procedure prior to filling out the
State Trait Anxiety Inventory (STAI) questionnaire. After their procedure, patients will fill
out the STAI questionnaire; Visual Analog Scales (VAS) for pain, satisfaction, and
discomfort; and Likert scales for patients to rate their music experience.
Music, when present, will be delivered via a speaker system allowing for communication
between the urologist and the patient during the procedure. Only one urologist will be
performing all flexible cystoscopies. Aside from the addition of music therapy for groups 1
and 2, standard of care will not be impacted.
Statistical analysis will be conducted by two-way ANCOVA comparing the mean of quantitative
outcome variables between the three music groups and each sex. In the event of a significant
interaction between the music and sex variables, one way-ANCOVA will be performed within each
sex, followed by Bonferroni-corrected post-hoc tests.
All data will be collected and stored appropriately as according to institutional policies as
well as any relevant chapters and sections of TCPS2.
Power analysis was performed to estimate the minimum sample size required to conduct the
proposed ANCOVA analyses. A review of relevant literature indicated effect sizes ranging from
small to large for both VAS and STAI scores. We therefore estimated our sample size using a
medium effect size to provide a reasonable common ground among findings in the literature.
Due to the 1:1:1 design for both sexes, we will target a sample size of 162 to allow for an
equal allocation of 27 participants per group.