跳至主要内容
临床试验/CTRI/2024/03/064493
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

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 584 人开始时间: 2024年4月1日最近更新:

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

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nirupama Varadhan

Mahatma Gandhi Medical College and Research Institute

研究点 (1)

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