Effect of Music and Lighting on Anxiety During Urodynamic Study (CALM-UDS)
Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
研究概览
详细说明
Urodynamic study (UDS) is an important diagnostic procedure for evaluating lower urinary tract dysfunction. Because UDS requires urethral and rectal catheterization, many patients experience anxiety before and during the procedure. This study is designed to evaluate whether environmental modifications, including relaxing music and dim lighting, reduce anxiety during UDS.
Approximately 220 adult participants are planned to be enrolled and randomly assigned in a 1:1:1:1 ratio to one of four groups: standard lighting without music, standard lighting with music, dim lighting without music, and dim lighting with music. Anxiety will be assessed before and after the procedure using the State-Trait Anxiety Inventory (STAI). Secondary outcome measures will include heart rate and blood pressure changes. The study will evaluate the independent and combined effects of music and lighting using a 2 × 2 factorial design.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mehmet Eflatun Deniz, MD
- 电话号码：+905304079085
- 邮箱：eflatun7@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 18 years or older.
- Scheduled to undergo urodynamic study (UDS) for clinical indications.
- Persistent lower urinary tract symptoms despite previous medical treatment or surgery.
- Able to understand the study procedures and complete the State-Trait Anxiety Inventory (STAI).
- Provided written informed consent.
Exclusion Criteria:
- Use of anxiolytic medications.
- Use of antiarrhythmic medications.
- Use of antihypertensive medications.
- Visual or hearing impairment that could interfere with the environmental interventions or completion of the questionnaire.
- Refusal or inability to complete the STAI questionnaire.
- Inability or unwillingness to provide informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Standard Lighting Without Music
Participants undergo urodynamic study under standard lighting without music.
|
Standard lighting (500 lux) during the urodynamic study.
|
|
实验性的：Standard Lighting With Music
Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.
|
Standard lighting (500 lux) during the urodynamic study.
Relaxing instrumental Zen-style music played during the urodynamic study.
|
|
实验性的：Dim Lighting Without Music
Participants undergo urodynamic study under dim lighting without music.
|
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
|
|
实验性的：Dim Lighting With Music
Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.
|
Relaxing instrumental Zen-style music played during the urodynamic study.
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in State-Trait Anxiety Inventory (STAI) Score
大体时间：Immediately before and immediately after the urodynamic study
|
The primary outcome is the change in State-Trait Anxiety Inventory (STAI) score from before to after the urodynamic study.
The STAI is a validated questionnaire used to assess anxiety, with higher scores indicating greater anxiety.
The change in score will be compared between the four intervention groups.
|
Immediately before and immediately after the urodynamic study
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KA25/238
计划个人参与者数据 (IPD)
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IPD 计划说明
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