Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study
研究概览
简要总结
This study aims to see if listening to recorded running water sounds during a bladder function test (urodynamic study) helps patients feel calmer and makes it easier for them to empty their bladder during the test. Bladder tests can cause anxiety or discomfort, which sometimes affects results. Playing running water sounds may help patients relax and improve their experience, based on earlier research. Participants will be randomly placed into one of two groups. One group will listens to running water sounds during the test while the other group will have the test done in the usual way without additional auditory intervention. Participants rate their anxiety before, during, and after the test using simple scales. Parameters of the test will be recorded for analysis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women aged 18-90 years scheduled for urodynamic study.
- •Understand written traditional Chinese.
- •Willing to participate and provide a written informed consent.
排除标准
- •Patients who refuse to participate or provide written consent.
- •Patients who do not understand or comprehend written traditional Chinese.
- •Patients with severe cognitive impairment or inability to complete the VAS.
- •Patients with known psychiatric conditions that may confound anxiety measurements.
- •Patients with hearing impairments that would prevent perception of the running water sound.
研究组 & 干预措施
Water sound
Standard urodynamics + running water sound
干预措施: Auditory intervention with running water sound (Behavioral)
Control
Standard urodynamics
结局指标
主要结局
Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study
时间窗: During the pressure-flow study phase of the urodynamic procedure
Maximum urinary flow rate (Qmax), defined as the peak flow rate during voluntary voiding with an indwelling catheter in place, measured in milliliters per second (mL/s) using standard urodynamic equipment. This parameter reflects bladder outlet function and is recorded automatically by the urodynamic system.
次要结局
- Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS)(Immediately before the start of the urodynamic procedure)
- Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS)(During the pressure-flow study phase of the urodynamic procedure)
- Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS)(Within 15 minutes after completion of the urodynamic procedure)
- Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study(During the pressure-flow study phase of the urodynamic procedure)
- Proportion of participants able to micturate (void) during pressure-flow study phase(During the pressure-flow study phase of the urodynamic procedure)
- Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic pressure-flow study(At the point of maximum urinary flow rate during the pressure-flow study)
- Bladder Contractility Index (BCI) calculated from urodynamic pressure-flow study(At the point of maximum urinary flow rate during the pressure-flow study)
研究者
Wong Siu Chung
Dr
Princess Margaret Hospital, Hong Kong