Recruiting

Music

Sponsor:

Horizon Health Network

Code:

NCT05429879

Conditions

Flexible Cystoscopy

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Preferred Music Arm

Classical Music Arm

Study Details

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

Study ID

NCT05429879

Start date

Jun 23, 2022

Status verified date

Jul, 2023

Completion date

May 30, 2024

Anticipated

Primary completion date

May 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Preferred Music Arm

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

experimental: Classical Music Arm

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

no intervention: No music Arm

Patients will not listen to music during cystoscopy.

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.

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.

Primary outcome measure

  • Post-Cystoscopy Anxiety Score [ Time Frame: Immediately after the procedure ]
  • Change in Anxiety Score from immediately before to immediately after cystoscopy (delta STAI) [ Time Frame: Change from immediately before the procedure to immediately after the procedure ]
  • Pelvic pain score [ Time Frame: Immediately after the procedure ]

Central Contacts and Locations

Central contacts

Locations

Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Contacts

Principal Investigator:

Gavin M Langille, MD

More Information

Sponsor

Horizon Health Network

Last update posted

Jul 14, 2023

Last verified

Jul, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Horizon Health Network on 2023-07-14.