The Impact of Music on Pain and Anxiety During Flexible Cystoscopies

NCT ID: NCT05429879

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2024-05-30

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.

Conditions

Flexible Cystoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preferred Music Arm

This arm will allow patients to listen to their preferred music choice during their cystoscopy.

Group Type: EXPERIMENTAL

Preferred Music Arm

Intervention Type: OTHER

Patients will choose their preferred music to be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.

Classical Music Arm

Patients will listen to a standard playlist of copyright free classical music.

Group Type: EXPERIMENTAL

Classical Music Arm

Intervention Type: OTHER

A standardized playlist of copyright free classical music will be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.

No music Arm

Patients will not listen to music during cystoscopy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preferred Music Arm

Patients will choose their preferred music to be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.

Intervention Type: OTHER

Classical Music Arm

A standardized playlist of copyright free classical music will be played during the cystoscopy procedure. No music will be played prior to or immediately after the flexible cystoscopy procedure. Music will be delivered via a speaker allowing for communication between the urologist and the patient during the procedure. Aside from addition of music, standard of care will not be impacted.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Horizon Health Network

OTHER

Sponsor Role: lead

Responsible Party

Gavin Langille

Staff Urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gavin M Langille, MD

Role: PRINCIPAL_INVESTIGATOR

Horizon Health Network, Dalhousie University Department of Urology

Locations

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Gavin M Langille, MD

Role: CONTACT

Gavin.Langille@Dal.ca

506-636-8818

Ali A Sherazi, BMSc

Role: CONTACT

Ali.Sherazi@Dal.ca

506-271-1199

Facility Contacts

Gavin M Langille, MD

Role: primary

Gavin.Langille@Dal.ca

506-636-8818

Ali A Sherazi, BMSc

Role: backup

Ali.Sherazi@Dal.ca

506-271-1199

Other Identifiers

101548

Identifier Type: -

Identifier Source: org_study_id