Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analog Scale for Anxiety (VAS-A)
研究概览
简要总结
This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.
The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 or above,
- •with a scheduled ERCP procedure
- •with the ASA grade level of I-II clinically
- •without a hearing/speech impairment
- •willing to participate in the research
- •without a mental problem or diagnosis of psychiatric disorder
- •without any a diagnosis of depression
排除标准
- •Patients with an emergency ERCP procedure
- •with a hearing/speech impairment
- •not willing to participate in the research
- •with a mental problem or diagnosis of psychiatric disorder
- •with a diagnosis of depression
结局指标
主要结局
Visual Analog Scale for Anxiety (VAS-A)
时间窗: 1 Hour
VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"
Visual Analog Scale for Pain (VAS)
时间窗: 2 Hours
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.
次要结局
- Vital Signs(4 hours)
研究者
Yeliz Ciğerci
Assistant Proffesor PhD
Afyonkarahisar Health Sciences University