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Health Care WorkersSEEKNCT02401607

SEEK Study - Study on Emergency Health Care Workers' Job Strain Evaluated by Karasek Questionnaire

An observational study of Health Care Workers, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Health Care Workers
What is being tested?
Karasek questionnaire and Saliva prelevement
How many people
100 participants
Where
1 siteFrance
Study dates
1 Jan 2015to May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: health care workers

Who may be able to join

  • Any health care workers from any emergency department of France

Who cannot join

  • Pregnancy
  • Refusal

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    lise laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr

    Frederic DUTHEIL

    Recruiting

Other trials in France

About this study

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.

Read more

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
Read the detailed description

Chronic stress at work is a public health problem increasing morbidity and mortality. Emergency physicians is particularly an at risk population. Indeed, their work is a complex interaction between stress due to life-threatening emergencies, the lack of sleep and accumulated fatigue.

A way of measuring stress at work is the use of self-reported psychological questionnaire. Among them, the Job control demand model from Karasek is widely used to evaluate psychosocial factors at work. The Karasek job strain model has been assessed in 25 000 workers in the Sumer study and allowed to classify the main types of occupations. However, no data regarding emergency physicians scores at the Karasek questionnaire were available, even though burnout exposure is a well-known problematic among health care workers. This absence is particularly unfortunate as emergency physicians often needs to deals with life threatening emergency in a short amount of time, following regularly long and craving shifts. A preliminary study with a low sample size reported in concrete terms the atypical "out of limit" situations of emergency physicians, with a decision latitude among the lowest and the highest psychological demand ever reported. Moreover, variation of stress at work has been linked with professional experiences. Karasek questionnaire is supposed to assess a long-term stable perception of work, despite the absence of study comparing Karasek scores within different conditions in the same participant. It is also important to explore protective factors that might help alleviate perceived stress and that are quite easy to integrate into medical organizations or in daily lifestyle.

Finally, several biomarkers of stress have been proposed. Among them, our team previously highlighted the potential of DHEAS to assess stress, due to its stability (steroid) and its long half-life of 16 hours. To our knowledge, the relationships between biomarkers of stress and the Karasek job strain model have never been investigated. Comparisons between emergency health care workers are also lacking.

Therefore, the general aim of this study is to enhance psychological well-being in emergency physicians. The primary objective is to verify our preliminary findings at Karasek scores on a large sample size of emergency physicians. The secondary objectives are to evaluate whether there is a change in perception of work both at short-term (on leave and after a 24-hour shift) and long-term (with professional experience). We will further explore its relationships with some biomarkers of stress and protective factors. Moreover, we aim to compare emergency health care workers specificity.

Questionnaires and saliva collection will be performed twice: at the beginning of a day work and at the end of a night work. Both measures will be recorded at the same time within each participant, between 6.30 am and 8.30 am depending of the health care workers. The time required by participant is evaluated to about 15min each time.

The same measures will be repeated every 5 year to assess long term changes in subjective and objective measures of stress.

The population description will be achieved with descriptive statistics. Continuous variables will be presented as mean and standard deviation, under the normality of distribution condition (Shapiro-Wilk needed).

The primary analysis will be mainly descriptive and will express (as a quantitative and categorical variables) the perception scores of emergency physicians work according to the Karasek questionnaire, for each dimensions composing the score (decision latitude, psychological demands and social support).

The evolution of the Karasek questionnaire score, obtained for each dimension, will be tested with a paired two-sample emergency physician's test (or nonparametric Wilcoxon test if necessary). Linear regression models or aleatory effects models (as described by Klar and Darlington, 2004, in Statistics in Medicine) will eventualy complete these analyzes. This will permit, with multivariate analyzes and the introduction of covariates, to seek for possible explanatory factors of the Karasek score and its evolution. The same process will be used for quantitative parameters that will be collected.

All statistical analyses will be performed as bilateral tests with a p <0.05 considered as significant. Statistical analyzes will be performed using STATA 16 software (Stata Corporation, College Station).

Being tested
Karasek questionnaire and Saliva prelevement
Keywords
emergency Medecine, biomarkers of stress, Food intake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Karasek questionnaire and Saliva prelevementOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: at day 1

  2. 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"

    Measured: at 5 years

  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"

    Measured: at 10 years

Secondary outcomes (5)
  1. Hamilton anxiety scale

    It is a psychological questionnaire used by clinicians to rate the severity of a patient anxiety.

    Measured: at day 1, at 5 years, 10 years

  2. Maslach Burn-out Inventory

    It is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout.

    Measured: at day 1, at 5 years, 10 years

  3. Hospital anxiety and depression scale

    It is used by doctors to determine the levels of anxiety and depression that a person is experiencing

    Measured: at day 1, at 5 years, 10 years

  4. Assessment of the food intake

    Questionnaire created by our team to assess the quantitative and qualitative food intake before, during and after a nightshift.

    Measured: at day 1

  5. Assessment of the salivary DHEA levels

    Salivary DHEA is a biomarker of stress

    Measured: at day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study start1 Jan 2015
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02401607
Sponsor's protocol ID
CHU-0228
Acronym
SEEK
Status last verified
Feb 2021
First submitted
16 Mar 2015
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33921527

Questions about this trial

What is this clinical trial studying?

An observational study of Health Care Workers, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Karasek questionnaire (time frame: at day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401607, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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