Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes During Urodynamic Testing: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Level During Procedure (VAS-P)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Music Arm
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.
干预措施: Behavioral: Music Listening (Behavioral)
Control Arm
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.
结局指标
主要结局
Pain Level During Procedure (VAS-P)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: T1: 0 minute (before procedure) (Score on a 0-10 scale)
Pain assessed with a 100 mm VAS (0 = no pain, 10 = worst pain).
次要结局
- Detrusor Pressure at Maximum Flow (PdetQmax)(Day 1, single measurement during voiding phase (cmH₂O))
- Maximum Flow Rate (Qmax)(Day 1, single measurement during voiding phase (mL/s))
研究者
YASEMİN ÖZHANLI
Assist Prof
Kocaeli University