NCT05633498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 1, 2026

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

November 21, 2022

Last Update Submit

April 30, 2026

Conditions

Shift-work Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Shift work disorder

    6 months

  • Knowledge about shift work and health

    6 months

  • Sick leave

    6 months

  • Turnover intention

    6 months

Study Arms (2)

Self-help book

EXPERIMENTAL

A self-help book for coping with shift work

Other: Book

Sleep hygiene advice

ACTIVE COMPARATOR

A sheet of paper with basic and standard sleep hygiene advice

Other: Sleep hygiene

Interventions

BookOTHER

Self-help book describing advice to cope with shift work

Self-help book
Sleep hygieneOTHER

Basic sleep hygiene advice on a piece of paper

Sleep hygiene advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms suggesting shift work disorder
  • Health care worker

You may not qualify if:

  • Below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 1, 2022

Study Start

November 18, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 1, 2026

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)