NCT02401607

Brief Summary

Emergency health care workers are exposed to job strain - defined by Karasek as a combination of high job demands and low job control. Emergency health care work is a complex interaction between stress due to life-threatening emergencies, overcrowding of the Emergency Department, the lack of sleep, bad food repartition during shifts, and accumulated fatigue. However, the Karasek questionnaire has never been assessed for Emergency Health Care workers. Furthermore, the variation of results during the career has never been assessed. The same measures will be repeated every 5 year to assess long term changes in subjective and objective measures of stress. The study's main objective is the creation of an Emergency Health Care worker's cohort to assess the evolution of the Karasek questionnaire during the follow-up. Secondary objectives are

  • the evaluation of the food intake before, during and after a nightshift.
  • the evaluation of other questionnaires

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

10.3 years

First QC Date

March 16, 2015

Last Update Submit

February 22, 2021

Conditions

Keywords

emergency Medecinebiomarkers of stressFood intake

Outcome Measures

Primary Outcomes (3)

  • Karasek questionnaire

    Karasek questionnaire is a self-reported psychological questionnaire. It defines job demands and job control as the two broad work-related characteristics present in the environment of most occupations that can be incredibly stressful. Workers can perceive both job demand and job control as being low or high. The combination of high job demands and low job control results in "Job Strain"

    at day 1

  • Karasek questionnaire

    Karasek questionnaire is a self-reported psychological questionnaire. It defines job demands and job control as the two broad work-related characteristics present in the environment of most occupations that can be incredibly stressful. Workers can perceive both job demand and job control as being low or high. The combination of high job demands and low job control results in "Job Strain"

    at 5 years

  • Karasek questionnaire

    Karasek questionnaire is a self-reported psychological questionnaire. It defines job demands and job control as the two broad work-related characteristics present in the environment of most occupations that can be incredibly stressful. Workers can perceive both job demand and job control as being low or high. The combination of high job demands and low job control results in "Job Strain"

    at 10 years

Secondary Outcomes (5)

  • Hamilton anxiety scale

    at day 1, at 5 years, 10 years

  • Maslach Burn-out Inventory

    at day 1, at 5 years, 10 years

  • Hospital anxiety and depression scale

    at day 1, at 5 years, 10 years

  • Assessment of the food intake

    at day 1

  • Assessment of the salivary DHEA levels

    at day 1

Interventions

Karasek questionniare and Saliva collection will be assessed on any health care worker working in any emergency department in France at day 1 and at 5 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

health care workers

You may qualify if:

  • Any health care workers from any emergency department of France

You may not qualify if:

  • Pregnancy
  • Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Bouillon-Minois JB, Trousselard M, Pereira B, Schmidt J, Clinchamps M, Thivel D, Ugbolue UC, Moustafa F, Occelli C, Vallet G, Dutheil F. Protocol of the Study on Emergency Health Care Workers' Responses Evaluated by Karasek Questionnaire: The SEEK-Study Protocol. Int J Environ Res Public Health. 2021 Apr 12;18(8):4068. doi: 10.3390/ijerph18084068.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

Study Officials

  • Frederic DUTHEIL

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 30, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations