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Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07207746
Enrollment
90
Registered
2025-10-06
Start date
2024-02-01
Completion date
2025-06-01
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Music Intervention, Nursing Care, Pain

Keywords

music intervention, pain, embarrassment, urodynamic testing

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.

Interventions

BEHAVIORALBehavioral: Music Listening

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

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.
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.
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).
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.

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026