- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01874704
Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial (JOBSTRESS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A stressful state can lead to symptoms of mental exhaustion and physical fatigue, detachment from work, and feelings of diminished competence. One of the health consequences of chronic stress at work is an increased risk of coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. In occupational medicine, no marker of stress or fatigue has achieved consensus. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare HRV in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We will also follow these markers three days following each shift (D3/24hS and D3/14hS).
The psychological consequences of shifts will be assessed in terms of perceived stress and fatigue using visual analog scales. Potential biomarkers will be assessed through urine and saliva collections. Heart rate variability will be measured using 5-lead electrocardiogram. Psychological questionnaires will be completed only once during the control day. The workload during each shift will be estimated by: the total number of entries, the number of admissions, the number of outpatients (collected by computer), and the number of life-and- death emergencies (given by the emergency physician). Sleep duration, including naps, will be assessed by questionnaire (bed time - wake time) on the three-day tracking of each shift and on the control day.
Shift randomization: Latin squares were used to randomize the pattern of shifts and control day (24hS then 14hS then control day or any other combination).
Gaussian distribution of the data wil be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between shifts will be made with ANOVA. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using SPSS Advanced Statistics software (SPSS Inc., Chicago, IL).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- emergency physician
Exclusion Criteria:
- endocrine disease, pregnancy, recent extraprofessional deleterious life event (such as death of a near relative, divorce), any current illness, drugs used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs), or any drugs with a chronotropic effect taken over the previous six months (beta blockers, diltiazem, verapamil, anxiolytics or antidepressants).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: biomarkers of stress
Comparison of biomarkers of stress in emergency physicians working a 24-hour shift or a 14-hour night shift
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Putative biomarkers of stress include heart rate variability (urinary and salivary steroids, saliva immunogobulin A, ...)
Time Frame: at day 1
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These biomarkers will be collected in emergency physicians
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
perceived stress measured using visual analog scale (VAS)
Time Frame: at day 1
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at day 1
|
perceived fatigue (VAS)
Time Frame: at day 1
|
at day 1
|
sleep duration (hours)
Time Frame: at day 1
|
at day 1
|
sleep quality (VAS)
Time Frame: at ady 1
|
at ady 1
|
workload within the emergency department during the shifts
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alain CHAMOUX, University Hospital, Clermont-Ferrand
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0154
- 2009-A01309-48
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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