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临床试验/CTRI/2024/09/074176
CTRI/2024/09/074176已完成不适用

Prevalence of Sleep Disorders, Associated Academic Performance and Sushupti Intervention: A Randomized Controlled Trial in the Undergraduate Students in Delhi, India

Delhi Pharmaceutical Sciences and Research University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
The primary outcome includes improvement in sleep latency, sleep duration, sleep efficiency, and sleep quality.

研究概览

简要总结

An innovative intervention titled "Sushupti Intervention" will be developed and validated for improving sleep quality. Sushupti is an integrated approach consisting of an education module related to sleep, components of Mind-body intervention, yoga, and Pilate exercises. The intervention will be implemented on students classified as poor sleepers according to the Pittsburgh Sleep Quality Index (PSQI). The sessions will be held three times a week over 12 weeks Baseline assessment (before initiation of intervention), intermediate assessment (at 6 weeks of intervention), and final assessment (after completion of intervention) will be conducted. A single-blinded Randomized Controlled Trial approach will be adopted to assess the efficacy of intervention on sleep among students. The assessment tools include pre- validated Harvard step test to examine cardiac fitness. Pittsburgh Sleep Quality Index (PSQI) to study sleep quality, Sleep Disorders Symptom Checklist (SDS-CL)-17 for examining the presence of symptoms of sleep disorder, and Menstrual Distress Questionnaire (MEDI-Q) to assess Menstrual distress among females. Lifestyle and screen time exposure assessment will be performed by using self- structured and validated tool.

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
18.00 Year(s) 至 24.00 Year(s)(—)
性别
All

入选标准

  • Enrolled in any undergraduate course in an educational institute under the boundaries of National Capital, Delhi.
  • Understands English.
  • Provide consent to participate.

排除标准

  • Student with any reported psychiatric disorder.
  • Do not understand English.

结局指标

主要结局

The primary outcome includes improvement in sleep latency, sleep duration, sleep efficiency, and sleep quality.

时间窗: Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention).

次要结局

  • The secondary outcome includes raised knowledge and awareness of sleep and its significance for health and overall productivity.(Baseline assessment (before initiation of intervention), intermediate assessment (at 6-weeks of intervention) and final assessment (at 12 weeks after completion of intervention).)

研究者

发起方
Delhi Pharmaceutical Sciences and Research University
申办方类型
Other [Government University]
责任方
Principal Investigator
主要研究者

Dr Puneeta Ajmera

Delhi Pharmaceutical Sciences and Research University

研究点 (1)

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