Skip to main content
OpenTrials
Completed

NCT Number: NCT07207746

Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

İzmit, Kocaeli, 41000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: Music Listening

Behavioral

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

Primary outcomes

  1. Pain Level at Baseline (VAS-P)

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

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

  2. Pain Level During Procedure (VAS-P)

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

    Pain assessed with a 100 mm VAS.

  3. Pain Level at End of Procedure (VAS-P)

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

    Pain assessed with a 100 mm VAS.

  4. Embarrassment Level at Baseline (VAS-E)

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

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

  5. Embarrassment Level During Procedure (VAS-E)

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

    Embarrassment assessed with a 100 mm VAS.

  6. Embarrassment Level at End of Procedure (VAS-E)

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

    Embarrassment assessed with a 100 mm VAS.

Secondary outcomes

  1. Maximum Flow Rate (Qmax)

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

    Maximum urine flow rate recorded during pressure-flow study.

  2. Detrusor Pressure at Maximum Flow (PdetQmax)

    Time frame: Day 1, single measurement during voiding phase (cmH₂O)

    Detrusor pressure measured at maximum urine flow.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes During Urodynamic Testing: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.