Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes

NCT07207746 | Completed

• 1 other identifier: 2024/01.03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Urodynamic testing (UDT) is a diagnostic procedure frequently used to evaluate lower urinary tract dysfunction, including urinary incontinence and voiding difficulties. Despite its diagnostic value, UDT is invasive and often causes discomfort, pain, and embarrassment due to catheter placement and repeated measurements. These negative experiences may reduce patient compliance, affect diagnostic accuracy, and increase reluctance to repeat the procedure. Music has been shown to promote relaxation and reduce pain and anxiety in various clinical settings, but its effect during urodynamic testing has not been adequately studied. This randomized controlled trial was designed to determine whether listening to music during invasive UDT can reduce pain and embarrassment while influencing urodynamic parameters.

Conditions

Nursing Care; Pain; Music Intervention

Keywords

music intervention; pain; embarrassment; urodynamic testing

Outcome Measures

Primary Outcomes (6)

• Pain Level at Baseline (VAS-P)

  Pain assessed with a 100 mm VAS (0 = no pain, 10 = worst pain).

  T1: 0 minute (before procedure) (Score on a 0-10 scale)

• Pain Level During Procedure (VAS-P)

  Pain assessed with a 100 mm VAS.

  T2: 15 minutes (during procedure) (Score on a 0-10 scale)

• Pain Level at End of Procedure (VAS-P)

  Pain assessed with a 100 mm VAS.

  T3: 30 minutes (end of procedure) (Score on a 0-10 scale)

• Embarrassment Level at Baseline (VAS-E)

  Embarrassment assessed with a 100 mm VAS (0 = no embarrassment, 10 = maximum embarrassment).

  T1: 0 minute (before procedure) (Score on a 0-10 scale)

• Embarrassment Level During Procedure (VAS-E)

  Embarrassment assessed with a 100 mm VAS.

  T2: 15 minutes (during procedure) (Score on a 0-10 scale)

• Embarrassment Level at End of Procedure (VAS-E)

  Embarrassment assessed with a 100 mm VAS.

  T3: 30 minutes (end of procedure) (Score on a 0-10 scale)

Secondary Outcomes (2)

• Maximum Flow Rate (Qmax)

  Day 1, single measurement during voiding phase (mL/s)

• Detrusor Pressure at Maximum Flow (PdetQmax)

  Day 1, single measurement during voiding phase (cmH₂O)

Study Arms (2)

Music Arm

EXPERIMENTAL

Participants in this group listened to slow-tempo (60-80 beats/min) instrumental classical music at a sound level of 40-60 dB throughout the urodynamic procedure (average 30 minutes). Music was delivered via headphones, starting before uroflowmetry and continuing until the end of voiding cystometry. Standard multi-channel urodynamic testing was performed according to the International Continence Society (ICS) Good Urodynamic Practice Guidelines. An 8 Fr cystometry catheter was inserted into the bladder to measure intravesical pressure, and a 4.5 Fr rectal catheter was used to measure intra-abdominal pressure. Urodynamic parameters including bladder capacity, leakage point pressure, detrusor contraction, maximum flow rate (Qmax), detrusor pressure at maximum flow (PdetQmax), and post-void residual volume were recorded. Pain and embarrassment were assessed at three time points: uroflowmetry, sitting on the table, and catheter insertion.

Behavioral: Behavioral: Music Listening

Control Arm

NO INTERVENTION

Participants in this group received standard care during the urodynamic procedure. No music intervention was applied. All procedures were performed under identical conditions following ICS Good Urodynamic Practice Guidelines, with the same catheter sizes and positioning protocol. Pain and embarrassment levels were assessed at the same three time points as in the music group. Urodynamic outcomes were recorded in parallel.

Interventions

Behavioral: Music Listening BEHAVIORAL

Participants listened to slow-tempo instrumental classical music (40-60 dB) via headphones during the entire urodynamic procedure.

Music Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged ≥18 years who are able to read and write
• Patients scheduled for urodynamic testing
• Patients with no visual, auditory, or cognitive impairments
• Patients without chronic pain

You may not qualify if:

• Patients who received sedation during the procedure.
• Pregnant women.
• Patients with a permanent urinary catheter.
• Patients with recurrent or active urinary tract infections.
• Patients requiring urodynamics due to urinary retention.
• Patients with a history of previous urodynamic testing

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

İzmit, Kocaeli, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied. While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Model Details: The study was conducted experimentally with a pre-test and post-test control group.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 6, 2025
• Study Start: February 1, 2024
• Primary Completion: February 5, 2024
• Study Completion: June 1, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)