Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes

Not Applicable

Completed

• Conditions: Nursing Care; Pain; Music Intervention

• Registration Number: NCT07207746
• Lead Sponsor: Kocaeli University

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.

Detailed Description

Urodynamic testing (UDT) is an outpatient diagnostic method used to assess bladder function in patients with lower urinary tract disorders such as urinary incontinence or voiding dysfunction. The procedure involves catheter insertion into the urethra, rectum, or vagina to measure intravesical, detrusor, and urethral pressure, and may include electromyographic evaluation of the external urethral sphincter. UDT typically consists of uroflowmetry, cystometry, and pressure-flow studies, during which urine flow rate and the relationship between intravesical pressure and urine flow are evaluated.

Although essential for diagnosis and treatment planning, UDT is often experienced as stressful and uncomfortable by patients. Pain, embarrassment, and emotional distress are frequently reported due to the invasive nature of catheter placement. These negative experiences may impair patient cooperation, affect the accuracy of urodynamic measurements, and reduce willingness to undergo repeated testing when required for monitoring. Nurses play a key role in preparing and supporting patients during UDT through education, positioning, catheter placement, privacy protection, and emotional support. However, evidence-based complementary strategies to improve patient comfort during UDT remain limited.

Music is a widely recommended nonpharmacological intervention that promotes relaxation, reduces anxiety and pain, and enhances patient satisfaction during invasive procedures. It is safe, cost-effective, and easy to implement. Previous studies have demonstrated that music can improve patient comfort in urological and gastrointestinal procedures, but no randomized controlled trials have specifically investigated its effect during UDT. Considering that patient anxiety and discomfort may influence urination and detrusor function during pressure-flow studies, interventions that improve comfort may also enhance test reliability.

This randomized controlled trial was therefore designed to evaluate the effect of listening to music during invasive urodynamic testing on patient-reported pain, embarrassment, and urodynamic outcomes. The results are expected to contribute to the evidence base for simple, safe, and cost-effective nursing interventions that improve patient comfort and cooperation during UDT.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-02-05
• Study Completion: 2025-06-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-27
• Last Update Submitted: 2025-09-27
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Level During Procedure (VAS-P)	T2: 15 minutes (during procedure) (Score on a 0-10 scale)	Pain assessed with a 100 mm VAS.
Pain Level at End of Procedure (VAS-P)	T3: 30 minutes (end of procedure) (Score on a 0-10 scale)	Pain assessed with a 100 mm VAS.
Embarrassment Level at Baseline (VAS-E)	T1: 0 minute (before procedure) (Score on a 0-10 scale)	Embarrassment assessed with a 100 mm VAS (0 = no embarrassment, 10 = maximum embarrassment).
Embarrassment Level During Procedure (VAS-E)	T2: 15 minutes (during procedure) (Score on a 0-10 scale)	Embarrassment assessed with a 100 mm VAS.
Embarrassment Level at End of Procedure (VAS-E)	T3: 30 minutes (end of procedure) (Score on a 0-10 scale)	Embarrassment assessed with a 100 mm VAS.
Pain Level at Baseline (VAS-P)	T1: 0 minute (before procedure) (Score on a 0-10 scale)	Pain assessed with a 100 mm VAS (0 = no pain, 10 = worst pain).

Secondary Outcome Measures

Name	Time	Method
Maximum Flow Rate (Qmax)	Day 1, single measurement during voiding phase (mL/s)	Maximum urine flow rate recorded during pressure-flow study.
Detrusor Pressure at Maximum Flow (PdetQmax)	Day 1, single measurement during voiding phase (cmH₂O)	Detrusor pressure measured at maximum urine flow.

Trial Locations

Locations (1)

Kocaeli University; İzmit, Kocaeli, Turkey (Türkiye)