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.
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
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
lise laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Frederic DUTHEIL
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).
- Conditions
- Health Care Workers
- 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.
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
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
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)
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
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
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
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
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.
- First posted30 Mar 2015 (estimated)
- Study start1 Jan 2015
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care WorkersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Association des Médecins des Urgences de Clermont-Ferrand, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEEK Study - Study on Emergency Health Care Workers' Job Strain Evaluated by Karasek Questionnaire
- ClinicalTrials.gov ID
- NCT02401607
- Acronym / sponsor ID
- SEEK / CHU-0228
- Conditions
- Health Care Workers
- Keywords
- emergency Medecine, biomarkers of stress, Food intake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Association des Médecins des Urgences de Clermont-Ferrand, Université d'Auvergne
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- health care workers
Key inclusion criteria (1 listed)
- Any health care workers from any emergency department of France
Key exclusion criteria (2 listed)
- Pregnancy
- Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karasek questionnaire and Saliva prelevementKarasek 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 | Other | – |
Primary outcome
Karasek questionnaire
Time frame: at day 1
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"
Karasek questionnaire
Time frame: at 5 years
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"
Karasek questionnaire
Time frame: at 10 years
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"
5 secondary outcomes
Hamilton anxiety scale
Time frame: at day 1, at 5 years, 10 years
Maslach Burn-out Inventory
Time frame: at day 1, at 5 years, 10 years
Hospital anxiety and depression scale
Time frame: at day 1, at 5 years, 10 years
Assessment of the food intake
Time frame: at day 1
Assessment of the salivary DHEA levels
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 33921527Bouillon-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
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.