The Impact of Music on Pain and Anxiety During Flexible Cystoscopies

NCT05429879 | Unknown

• 1 other identifier: 101548
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexible Cystoscopy

Keywords

Flexible cystoscopy; Music therapy; Urology; Anxiety; Pain; Satisfaction; Discomfort; Preferred music; Classical music

Outcome Measures

Primary Outcomes (3)

• Post-Cystoscopy Anxiety Score

  Anxiety score is measured using the State Trait Anxiety Inventory (STAI). The STAI consists of two questionnaires that classifies a patient's anxiety into three groups on a scale of 20 to 80. The STAI includes two component questionnaires known as State Anxiety and Trait Anxiety. Trait Anxiety corresponds with stable individual anxiety measures while State Anxiety refers to anxiety that an individual is experiencing at a specific given moment at time. As described by the State-Trait Anxiety Inventory for Adults manual, people with higher Trait Anxiety measures may have elevated State Anxiety measures as compared to people with lower Trait Anxiety. In our study, Trait Anxiety will be controlled for, since differences in Trait Anxiety may confound State Anxiety measurements due to the individual being naturally more anxious due to unrelated reasons. A higher STAI anxiety score indicates higher anxiety.

  Immediately after the procedure

• Change in Anxiety Score from immediately before to immediately after cystoscopy (delta STAI)

  The delta State Trait Anxiety Inventory (delta STAI) is a measure of the change in STAI anxiety score immediately after the cystoscopy minus STAI anxiety score immediately prior to the cystoscopy. The delta STAI ranges on a scale from negative 60 to positive 60. A positive delta STAI score indicates that there was a greater STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A higher positive delta STAI score means a greater increase in anxiety as compared to a lower delta STAI score. A negative delta STAI score indicates that there was a lower STAI anxiety score immediately after the procedure as compared to immediately before the procedure. A more negative delta STAI score indicates a greater decrease in anxiety as compared to a less negative delta STAI score. A delta STAI score of 0 indicates that there was no change in STAI anxiety score from immediately before the procedure to immediately after the procedure.

  Change from immediately before the procedure to immediately after the procedure

• Pelvic pain score

  Pelvic pain will be measured using a Visual Analog Scale (VAS). The VAS score is completed by the patient ranking their pain intensity on 10-cm lines and providing a range of scores from 0 to 100. This measure is then converted to a score of 10 (to 1 decimal eg. 8.2/10). For this study, VAS scales will be filled out by the patient immediately following their cystoscopy. A higher VAS score indicates greater self reported pelvic pain.

  Immediately after the procedure

Secondary Outcomes (6)

• Pelvic discomfort score

  Immediately after the procedure

• Patient satisfaction score

  Immediately after the procedure

• Willingness to repeat cystoscopy score

  Immediately after the procedure

• How pleasant patients from music intervention groups found the music

  Immediately after the procedure

• How calming patients from music intervention groups found the music

  Immediately after the procedure

Study Arms (3)

Preferred Music Arm

EXPERIMENTAL

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

Other: Preferred Music Arm

Classical Music Arm

EXPERIMENTAL

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

Other: Classical Music Arm

No music Arm

NO INTERVENTION

Patients will not listen to music during cystoscopy.

Interventions

Preferred Music Arm 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.

Preferred Music Arm

Classical Music Arm 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.

Classical Music Arm

Eligibility Criteria

• Age: 40 Years - 100 Years
• Gender Eligibility Details: 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. This design is to appropriately account for potential differences in cystoscopy experience for males and females, due to differences in ureter length and anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Horizon Health Network: lead
• Dalhousie University: collaborator

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gavin M Langille, MD

  Horizon Health Network, Dalhousie University Department of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavin M Langille, MD

CONTACT

506-636-8818; Gavin.Langille@Dal.ca

Ali A Sherazi, BMSc

CONTACT

506-271-1199; Ali.Sherazi@Dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Urologist

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 23, 2022
• Study Start: June 23, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)