Combination of Video and Written Information Provides the Patient With a More Comprehensive Level of Knowledge About Endoscopic Retrograde Cholangiopancreatography: Study Protocol for Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- time for informed consent practices before ERCP
研究概览
简要总结
To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 否
入选标准
- •All inpatients who will receive ERCP
排除标准
- •under 18 years or more than 70 years
- •pregnancy or breast-feeding women
- •circulatory and respiratory disorders
- •mental illness
研究组 & 干预措施
written informed consent
participants read the written informed consent documents befor ERCP
干预措施: written informed consent (Procedure)
video+written informed consent
participants watch a video about the ERCP and read the written informed consent documents before ERCP
干预措施: video+written informed consent (Procedure)
结局指标
主要结局
time for informed consent practices before ERCP
时间窗: 2 days
time for extra explanation about ERCP
时间窗: 2 days
次要结局
- satisfaction degree about the informed consent practices(2 days)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital