Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Questionnaire
研究概览
简要总结
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being a being bariatric metabolic surgery candidate according to international guidelines
排除标准
- •illiterate
- •previous bariatric surgery
研究组 & 干预措施
only informed consent
The first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards.
干预措施: non-video group (Behavioral)
video assisted group
The second group got an additional information video presentation and then the same quiz.
干预措施: non-video group (Behavioral)
video assisted group
The second group got an additional information video presentation and then the same quiz.
干预措施: video assisted group (Behavioral)
结局指标
主要结局
Questionnaire
时间窗: six months
In the video group : verbal-written consent + video presentation In the conventional consent group: only verbal-written consent The video consisted of a summary of the written informed consent. Questionnaire consist of 15 questions quiz was given to both groups. Each question was rated on 15 points. 1point = bad score means don't understand informed consent. 15 point = full score means good understanding.
次要结局
未报告次要终点
研究者
Kutay Saglam
MD, Gastrointestinal Surgery Fellow
Inonu University