Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy
详细描述
The study was conducted with the participation of 96 patients who were referred for endoscopy for various reasons. Data were collected by two researchers. Patients between the ages of 18-70 who had scheduled upper gastrointestinal endoscopy appointments were included in the study, regardless of gender and underlying diseases. Patients who had undergone endoscopic procedures before, were using medication for anxiety and panic disorders, required urgent endoscopic intervention, had advanced dementia, had hearing problems, had anatomical or inflammatory disorders in the external ear canals, and those who did not want to listen to music for 15 minutes before the procedure were not included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments
排除标准
- •Anxiety and panic disorders
- •Urgent endoscopic intervention
- •Advanced dementia
- •Hearing problems
- •Anatomical or inflammatory disorders in the external ear canals
结局指标
主要结局
State-Trait Anxiety Inventory (STAI)
时间窗: Within 20 minutes pre-procedure and 5 minutes after the procedure
Comparative results of the differences in STAI scores before and 5 minutes after the endoscopy in the music and control groups. The State-Trait Anxiety Inventory (STAI) is a valid, self-report measure that consists of 40 items, with 20 items assessing state anxiety (STAI-S) and the other 20 items assessing trait anxiety (STAI-T). For both state and trait components, scores range from 20 to 80, with higher scores indicating higher levels of anxiety
次要结局
- Heart rate(Within 20 minutes pre-procedure and 5 minutes after the procedure)
- Patient satisfaction(5 minutes after the procedure)
- Blood pressure(Within 20 minutes pre-procedure and 5 minutes after the procedure)
- patient tolerance(During the procedure)
研究者
selim demirci
medical doctor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital