EFFECTIVENESS OF PSYCHOBEHAVIOURAL INTERVENTIONS FOR SLEEP DISTURBANCES IN UNDER GRADUATE MEDICAL STUDENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To assess the quality of sleep and severity of insomnia
研究概览
简要总结
Purpose: To explore the effectiveness of psychobehavioural interventions in improving the quality of sleep.
Design: Open label, Randomized controlled trial
Participants: Undergraduate medical students above the age of 18 years with poor sleep quality.
Intervention: One arm will receive mindfulness based therapy and the other arm will receive sleep hygiene education.
Main outcome measure: To assess the quality of sleep and severity of insomnia in both the arms at baseline and after providing the intervention at the end of 4 weeks and 12 weeks.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 随机化方法
- Computer generated randomization
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 19.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- Undergraduate medical students with poor sleep quality and willing to provide informed consent.
排除标准
- Participants with medical conditions that is known to impact sleep, major psychiatric disorders and unwilling to participate in the study will be excluded.
结局指标
主要结局
To assess the quality of sleep and severity of insomnia
时间窗: At baseline and at the end of 4 weeks and 12 weeks after providing intervention
次要结局
- To assess the mindfulness skills(At baseline and at the end of 4 weeks and 12 weeks after providing intervention which is)
研究者
研究点 (1)
标识符
- CTRI 编号
- CTRI/2021/10/037125
日期
- 最近更新
- (5年前)
监管与共享
- 个体参与者数据共享计划
- 是
Will individual participant data (IPD) be shared publicly (including data dictionaries)? Response - YES What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). What additional supporting information will be shared? Response (Others) - Who will be able to view these files? Response - Anyone For what types of analyses will this data be available? Response - Any purpose. By what mechanism will data be made available? Response (Others) - For how long will this data be available start date provided 21-06-2022 and end date provided 21-07-2025 ? Response - Immediately following publication. No end date. Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL