Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Change in State-Trait Anxiety Inventory (STAI) Score
研究概览
简要总结
This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Anxiety levels before and after the procedure will be assessed using the State-Trait Anxiety Inventory (STAI). The study aims to determine the independent and combined effects of music and lighting on patient anxiety during UDS.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Lighting Without Music
Participants undergo urodynamic study under standard lighting without music.
干预措施: Standard Lighting (Other)
Standard Lighting With Music
Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.
干预措施: Standard Lighting (Other)
Standard Lighting With Music
Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.
干预措施: music (Other)
Dim Lighting Without Music
Participants undergo urodynamic study under dim lighting without music.
干预措施: Dim lighting (Other)
Dim Lighting With Music
Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.
干预措施: music (Other)
Dim Lighting With Music
Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.
干预措施: Dim lighting (Other)
结局指标
主要结局
Change in State-Trait Anxiety Inventory (STAI) Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Mehmet Eflatun Deniz
Assistant Professor
Baskent University Ankara Hospital