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Clinical Trials/NCT03605732
NCT03605732CompletedNot Applicable

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 sites in 1 country312 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
312
Locations
2
Primary Endpoint
Sleep Quality

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: 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

Intervention: patients education (Other)

Outcomes

Primary Outcomes

Sleep Quality

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amir H Pakpour

Supervisor

Qazvin University Of Medical Sciences

Study Sites (2)

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