Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- Evaluation of Comprehension of Informed Consent Process via a scored scale
研究概览
简要总结
The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.
详细描述
IC = informed consent
The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
- •Had to be undergoing pediatric endoscopy.
- •English speaking
排除标准
- 未提供
结局指标
主要结局
Evaluation of Comprehension of Informed Consent Process via a scored scale
时间窗: Day 1
Structured Interview
次要结局
未报告次要终点
研究者
Jeannie Huang, MD, MPH
Associate Professor
Huang, Jeannie, M.D.