Self-help Book for Shift Work Related Problems

Sponsor

University of Bergen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05633498

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Shift-work Disorder	Other: Book Other: Sleep hygiene	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of a Self-help Book for Shift Work Related Problems - a Randomized Controlled Trial

Actual Study Start Date :

Nov 18, 2022

Anticipated Primary Completion Date :

Nov 18, 2024

Anticipated Study Completion Date :

Nov 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-help book A self-help book for coping with shift work	Other: Book Self-help book describing advice to cope with shift work
Active Comparator: Sleep hygiene advice A sheet of paper with basic and standard sleep hygiene advice	Other: Sleep hygiene Basic sleep hygiene advice on a piece of paper

Arm

Intervention/Treatment

Experimental: Self-help book

A self-help book for coping with shift work

Other: Book

Self-help book describing advice to cope with shift work

Active Comparator: Sleep hygiene advice

A sheet of paper with basic and standard sleep hygiene advice

Other: Sleep hygiene

Basic sleep hygiene advice on a piece of paper

Outcome Measures

Primary Outcome Measures

Sleep problems [6 months]
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.
Sleepiness problems [6 months]
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.

Secondary Outcome Measures

Shift work disorder [6 months]
Prevalence of shift work disorder based on international criteria
Knowledge about shift work and health [6 months]
Questions about sleep, circadian rhythms and shift work
Sick leave [6 months]
Self-reported sickness absence
Turnover intention [6 months]
Self-reported turnover intention on a validated scale (TI) with scores ranging from 0 to 4 with higher values indicating more turnover intention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Symptoms suggesting shift work disorder
Health care worker

Exclusion Criteria:

Below 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bergen	Bergen	Hordaland	Norway	5018

Sponsors and Collaborators

University of Bergen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Bergen

ClinicalTrials.gov Identifier:

NCT05633498

Other Study ID Numbers:

HEWOS_RCT_SWD2022

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 5, 2022