CTRI/2024/03/064493已完成4 期
Effect of audiovisual aided informed consent on knowledge and anxiety levels among patients undergoing elective cataract surgery – A Randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- Comparing knowledge and anxiety levels among patients undergoing elective cataract surgery using tradional informed consent process and audiovisual aided informed consent
研究概览
简要总结
There are not many studies done on the effect of audiovisual aids on informed consent process for cataract surgery in a rural population in India. The use of a video for informed consent process is also not much in use. If the use of video in informed consent for cataract surgery is found to be effective, it will help in making the informed consent procedure more uniform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 95.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients planned for their first eye elective cataract surgery.
排除标准
- •Patients who are hard of hearing Patients with poor comprehension Patients who cannot give legal consent Patients with visual acquity of less than 3/60 in the better eye.
结局指标
主要结局
Comparing knowledge and anxiety levels among patients undergoing elective cataract surgery using tradional informed consent process and audiovisual aided informed consent
时间窗: Before administering consent and 24 hours after administering consent
次要结局
未报告次要终点
研究者
Nirupama Varadhan
Mahatma Gandhi Medical College and Research Institute
研究点 (1)
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