Clinical trial NCT05429879: The Impact of Music on Pain and Anxiety During Flexible Cystoscopies
Official title: The Impact of Music on Pain and Anxiety During Flexible Cystoscopies: A Comparison Between the Patient's Preferred Music, Classical Music, and the Absence of Music
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexible Cystoscopy
Keywords: Flexible cystoscopy
Music therapy
Urology
Anxiety
Pain
Satisfaction
Discomfort
Preferred music
Classical music
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2022-06-23
Enrollment: 162
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized control study that is designed to study outcomes between subjects. Participants will be randomly assigned to one of three groups and will be stratified according to sex. Stratified randomization will be done by selection of sequential pre-filled envelopes containing the group for a particular patient at the time of cystoscopy - This is a 1:1:1 randomization with equal group membership performed for both male and female sexes - The envelopes will be randomized by pre-assigning an order of participants to each of the three groups within each sex using a Random sequence generator.
Primary purpose: TREATMENT

Brief summary: Background: Cystoscopy is a routine diagnostic test often performed in the outpatient Urology setting. However, patients may sometimes feel pain and anxiety during this procedure. Distraction therapies, including patient preferred music and classical music may reduce pain and anxiety associated with cystoscopy. However, it is unclear if patient preferred music has greater positive outcomes for patients than classical music.

Hypothesis: We hypothesize that patient preferred music during flexible cystoscopies will reduce patient self-reported pain and anxiety scores when compared to classical music and absence of music.

Objective: To assess whether a patient's preferred music reduces pain and anxiety during cystoscopies when compared to classical music and the absence of music Methods: This is a prospective randomized control study where patients undergoing flexible cystoscopy in the outpatient Urology clinic will be randomly assigned to one of three groups: Preferred music, classical music, or no music for their procedure. Differences in pain and anxiety will be assessed between groups using the Visual Analog Scale and State-Trait Anxiety Inventory scale.

Potential Benefits: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All outpatient men and women needing diagnostic or surveillance flexible cystoscopy.
* 40 years or older.
* Presenting to outpatient urology clinic.

Exclusion Criteria:

* Narcotics/analgesics within the past 24 hours
* Stricture/anatomic urethra problems
* Current UTI
* Inability to complete survey or comply with experimental methods,
* Refusal to participate
* Rigid cystoscopy
* Manipulation during cystoscopy (stent removal, fulguration tumor, etc)
* Pre-existing chronic pelvic pain condition/diagnosis

Primary outcomes:
measure: Post-Cystoscopy Anxiety Score
timeFrame: Immediately after the procedure
measure: Change in Anxiety Score from immediately before to immediately after cystoscopy (delta STAI)
timeFrame: Change from immediately before the procedure to immediately after the procedure
measure: Pelvic pain score
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Pelvic discomfort score
timeFrame: Immediately after the procedure
measure: Patient satisfaction score
timeFrame: Immediately after the procedure
measure: Willingness to repeat cystoscopy score
timeFrame: Immediately after the procedure
measure: How pleasant patients from music intervention groups found the music
timeFrame: Immediately after the procedure
measure: How calming patients from music intervention groups found the music
timeFrame: Immediately after the procedure
measure: How much patients from music intervention groups found that music helped distract them from the cystoscopy procedure
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
Study officials:
affiliation: Horizon Health Network, Dalhousie University Department of Urology
name: Gavin M Langille, MD
role: PRINCIPAL_INVESTIGATOR
References: