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临床试验/NCT03605732
NCT03605732已完成不适用

The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Employees of Qazvin University of Medical Sciences

Qazvin University Of Medical Sciences2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
2
主要终点
Sleep Quality

研究概览

简要总结

This plan will be implemented on the staff of the Qazvin University of Medical Sciences. The Insomnia Severity Index questionnaire will be used to screen for insomnia and low sleep health. This questionnaire is provided online to the staff through communication channels such as telegrams to help people who are interested in participating in this research. Individuals who scored more than 8 were randomly assigned to intervention and control groups and completed the Insomnia Index Index. The intervention group will then receive an app-based educational intervention designed to improve sleep hygiene. Control group: Participants in the control group perform routine activities. The intervention and control group will fill out the relevant questionnaire one and three and six months after the completion of the training to assess the impact of the intervention online.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical level of Insomnia (more than 10 on ISI)
  • Meets criteria for Insomnia according to DSM-IV-TR
  • Enough language skills
  • Have access to an Android smartphone or a desktop computer with Internet access
  • Participants will be required to sign an informed consent form

排除标准

  • Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
  • Alcohol/drugs abuse
  • Participation in other trials concurrently
  • pregnancy
  • having children under 2 years old
  • Not having an internet-connected computer, cellular phone or tablet
  • Working night shifts
  • Somatic or psychiatric conditions requiring acute care

研究组 & 干预措施

intervention

Experimental

Intervention group: They will receive an educational app designed to improve sleep, and will receive self-help training in a six-week training package.

干预措施: self help sleep hygiene intervention application (Behavioral)

Patient education

Active Comparator

Patients will receive written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors

干预措施: patients education (Other)

结局指标

主要结局

Sleep Quality

时间窗: changes in PSQI baseline , 1 month, 3 months and 6 months follow-up

The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep. The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month. The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep

sleep hygiene behavior

时间窗: changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up

Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene. behaviour.

次要结局

  • Anxiety and Depression(changes in Anxiety and Depression baseline , 1 month, 3 months and 6 months follow-up)
  • Psychological predictors of sleep hygiene behavior (intention, planning, outcome expectancies,Habit,Self-monitoring,Self-efficacy)(changes from baseline , changes from baseline , 1 month and 6 Months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir H Pakpour

Supervisor

Qazvin University Of Medical Sciences

研究点 (2)

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