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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05633498
Other study ID # HEWOS_RCT_SWD2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 18, 2022
Est. completion date March 18, 2025

Study information

Verified date May 2024
Source University of Bergen
Contact Bjørn Bjorvatn, PhD
Phone +4791140269
Email bjorn.bjorvatn@uib.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to assess whether a self-help book for coping with shift work will reduce complaints in relation to shift work.


Description:

This study is a randomized controlled trial evaluating the effect of a self-help book for shift work related problems compared to the effect of sleep hygiene advice in participants with shift work disorder. 300 participants will be randomized to receive either the book or the sleep hygiene advice. Participants complete questionnaires about sleep, sleepiness and health at baseline and after 6 months after receiving the written material. The main aims are to assess whether the book is more effective to reduce sleep and sleepiness problems in relation to shift work, and to reduce the prevalence of shift work disorder, to increase knowledge about sleep and circadian rhythms, improve health, and reduce turnover intention.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 18, 2025
Est. primary completion date March 18, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Symptoms suggesting shift work disorder - Health care worker Exclusion Criteria: - Below 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Book
Self-help book describing advice to cope with shift work
Sleep hygiene
Basic sleep hygiene advice on a piece of paper

Locations

Country Name City State
Norway University of Bergen Bergen Hordaland

Sponsors (1)

Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep problems Self-reported sleep problems in relation to shift work on a validated scale - Bergen Shift Work Sleep Questionnaire (BSWSQ). Questions range from 0 to 4 with higher values indicating more sleep problems. 6 months
Primary Sleepiness problems Self-reported sleepiness in relation to shift work on a validated scale - Bergen Shift Work Sleep Questionnaire (BSWSQ). Questions range from 0 to 4 with higher values indicating more sleepiness. 6 months
Secondary Shift work disorder Prevalence of shift work disorder based on international criteria 6 months
Secondary Knowledge about shift work and health Questions about sleep, circadian rhythms and shift work 6 months
Secondary Sick leave Self-reported sickness absence 6 months
Secondary Turnover intention Self-reported turnover intention on a validated scale (TI) with scores ranging from 0 to 4 with higher values indicating more turnover intention. 6 months
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