Heart Rate VariabilityJOBSTRESSNCT04334083
Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
A study testing Comparison of biomarkers of stress in people with Heart Rate Variability, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Emergency medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Comparison of biomarkers of stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2022to 21 Dec 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency physicians from the emergency department of CHU Clermont-Ferrand will be accompanied by a medical externship student.
- Ability to give a written informed consent.
Who cannot join
- Participant refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Emergency medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Consequently, stress may lead to symptoms of mental exhaustion, physical fatigue, detachment from work, and feelings of diminished competence . Emergency physicians (EPs) are exposed to a complex interplay between stress (life-and-death emergencies - a defining characteristic of their job), sleep deprivation, and fatigue due to repeated changes in, and duration of shifts. Work-related exhaustion can lead to various physical and psychological symptoms, and also may be associated with delayed decision-making . The combined effects of stress and fatigue can impact on job performance, often resulting in otherwise preventable medical errors. Moreover, prolonged stress may expose EPs to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease. All these contribute to the premature departure of EPs to other specialties. Furthermore, low HRV has been associated with stress, burnout, and is linked with an increased risk of cardiovascular diseases.
This project proposes to evaluate if life-and-death emergencies or specific situations will induce abrupt changes in HRV among emergency physicians. Moreover, we would like to compare reactions between being an actor (EPs) and being a spectator and assess the role of expertise and habituation to stressful emergency situations.
Read the detailed description
The JOBSTRESS protocol was designed to provide a better understanding of the association between specific situations (ie: life and death emergencies) and breaks in the variability of the heart rate. Each emergency physician participates in the study two times. A night shift from 6:30 p.m to 8:30 a.m (14 hours) which will be compared with a day shift, as a control, from 8:30 a.m to 6:30 p.m. Emergency physicians will be accompanied by a medical externship student.
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be bilateral and a p <0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, average, median, standard deviation, and range. Graphic representations will be complete presentations of results. We process multivariate physiological series (HR, HRV, SC, wrist motion, respiratory rate) in order to build a stress index. For such multivariate physiological series, we first use change point analysis on each univariate series in order to get clusters with constant parameters, then we use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, we obtain at each time the level of stress and can compare it to the environmental conditions.
- Conditions
- Heart Rate Variability
- Being tested
- Comparison of biomarkers of stress
- Keywords
- Heart rate variability, stress, cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of biomarkers of stressBehavioural
Emergency will be followed during a night shift and the rest day et during a day shift and the rest day. They will be observed by a medical externship student. We will assess the role of expertise and habituation to stressful emergency situations.
| Study group | Role | What they receive |
|---|---|---|
| Emergency physicians | Experimental | actors during the work Receives: Behavioral: Comparison of biomarkers of stress |
| medical externship student | Experimental | spectator during the emergency physician work Receives: Behavioral: Comparison of biomarkers of stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability at night work
measure of abrupt changes in HRV signals during 14 hours
Measured: from 18:30 to 8:30, during the 14 hours of the night shift
heart rate variability at day work
measure of abrupt changes in HRV signals during 10 hours
Measured: from 8:30 to 18:30, during the 10 hours of the day shift
Secondary outcomes (67)
Stress
measure of stress using VAS
Measured: 18:30, baseline of the night shift
Fatigue
measure of Fatigue using VAS
Measured: at 18:30, baseline of the night shift
Stress
measure of stress using VAS
Measured: at 8h30, at the end of the night shift
Fatigue
measure of Fatigue using VAS
Measured: at 8:30, at the end of the night shift
Stress
measure of stress using VAS
Measured: at 8:30, 24 hours after the end of night shift
Fatigue
measure of Fatigue using VAS
Measured: at 8:30, 24 hours after the end of night shift
Fatigue
measure of Fatigue using VAS
Measured: at 18:30, 24 hours after the end of day shift
Stress
measure of stress using VAS
Measured: at 18:30, 24 hours after the end of day shift
Stress
measure of stress using VAS
Measured: at 8:30, baseline of the day shift
Fatigue
measure of Fatigue using VAS
Measured: at 8:30, baseline of the day shift
Stress
measure of stress using VAS
Measured: at 18:30, end of the day shift
Fatigue
measure of Fatigue using VAS
Measured: at 18:30, end of the day shift
Saliva biomarkers cortisol
measure of Cortisol
Measured: at 18:30, baseline of the night shift
Saliva biomarkers cortisol
measure of Cortisol
Measured: at 8:30, at the end of the night shift
Saliva biomarkers cortisol
measure of Cortisol
Measured: at 8:30, baseline of the day shift
Saliva biomarkers cortisol
measure of Cortisol
Measured: at 18:30, end of the day shift
Saliva biomarkers DHEAS
measure of DHEAS
Measured: at 18:30, baseline of the night shift
Saliva biomarkers DHEAS
measure of DHEAS
Measured: at 8:30, at the end of the night shift
Saliva biomarkers DHEAS
measure of DHEAS
Measured: at 8:30, baseline of the day shift
Saliva biomarkers DHEAS
measure of DHEAS
Measured: at 18:30, end of the day shift
Saliva biomarkers lgAs
measure of lgAs
Measured: at 18:30, baseline of the night shift
Saliva biomarkers lgAs
measure of lgAs
Measured: at 8:30, at the end of the night shift
Saliva biomarkers lgAs
measure of lgAs
Measured: at 8:30, baseline of the day shift
Saliva biomarkers lgAs
measure of lgAs
Measured: at 18:30, end of the day shift
blood samples full blood count
measure of full blood count
Measured: at 8:30, at the end of the night shift
blood samples full blood count
measure of full blood count
Measured: at 8:30, baseline of the day shift
blood samples HbA1c,
measure of HbA1c
Measured: at 8:30, at the end of the night shift
blood samples HbA1c,
measure of HbA1c
Measured: at 8:30, baseline of the day shift
blood samples HDLc and LDL-cholesterol
measure of HDLc and LDL-cholesterol
Measured: at 8:30, at the end of the night shift
blood samples HDLc and LDL-cholesterol
measure of HDLc and LDL-cholesterol
Measured: at 8:30, baseline of the day shift
blood samples TG
measure of TG
Measured: at 8:30, at the end of the night shift
blood samples TG
measure of TG
Measured: at 8:30, baseline of the day shift
blood samples Cortisol
measure of Cortisol
Measured: at 8:30, at the end of the night shift
blood samples Cortisol
measure of Cortisol
Measured: at 8:30, baseline of the day shift
blood samples DHEAS
measure of DHEAS
Measured: at 8:30, at the end of the night shift
blood samples DHEAS
measure of DHEAS
Measured: at 8:30, baseline of the day shift
blood samples vitamine D
measure of vitamine D
Measured: at 8:30, at the end of the night shift
blood samples vitamine D
measure of vitamine D
Measured: at 8:30, baseline of the day shift
blood samples BDNF
measure of BDNF
Measured: at 8:30, at the end of the night shift
blood samples BDNF
measure of BDNF
Measured: at 8:30, baseline of the day shift
blood samples proinflammatory cytokines
measure of proinflammatory cytokines
Measured: at 8:30, at the end of the night shift
blood samples proinflammatory cytokines
measure of proinflammatory cytokines
Measured: at 8:30, baseline of the day shift
blood samples telomeres lengh
measure of telomeres lengh
Measured: at 8:30, at the end of the night shift
blood samples telomeres lengh
measure of telomeres lengh
Measured: at 8:30, baseline of the day shift
Burnout
Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".
Measured: day 1
Depression
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
Measured: day 1
Anxiety
Anxiety is assessed by the the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always" and by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always".
Measured: day 1
Life satisfaction
quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)
Measured: day 1
Lifestyle
Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).
Measured: day 1
Life and occupational events
Assessing factors regarding death of patients or death of a loved one by questionnaire.
Measured: day 1
Sick leave
assessing sick leave by the number of absence days the previous 6 months using a questionnaire
Measured: day 1
Clinical measurements height
measure of height
Measured: day 1
Clinical measurements weight
measure of weight
Measured: day 1
diastolic blood pressure
measure of diastolic blood pressure
Measured: at 18:30, baseline of the night shift
systolic blood pressure
measure of systolic blood pressure
Measured: at 18:30, baseline of the night shift
diastolic blood pressure
measure of diastolic blood pressure
Measured: at 8:30, at the end of the night shift
systolic blood pressure
measure of systolic blood pressure
Measured: at 8:30, at the end of the night shift
diastolic blood pressure
measure of disatolic blood pressure
Measured: at 8:30, baseline of the day shift
systolic blood pressure
measure of systolic blood pressure
Measured: at 8:30, baseline of the day shift
diastolic blood pressure
measure of disatolic blood pressure
Measured: at 18:30, end of day shift
systolic blood pressure
measure of systolic blood pressure
Measured: at 18:30, end of day shift
skin conductance
measure of the skin conductance
Measured: from 18:30 to 8:30, during the 14 hours of night shift
skin conductance
measure of the skin conductance
Measured: from 8:30 to 18:30, during the 10 hours of day shift
Genetic factors ACE
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Measured: at 8:30, end of the night shift
Genetic factors ACE
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Measured: at 8:30, baseline of the day shift
Genetic factors (5-HTT)
measure of the polymorphism of the serotonin transporter (5-HTT)
Measured: at 8:30, end of the night shift
Genetic factors (5-HTT)
measure of the polymorphism of the serotonin transporter (5-HTT)
Measured: at 8:30, baseline of the day shift
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start17 Feb 2022
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
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 Heart Rate VariabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Dutheil, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334083
- Sponsor's protocol ID
- RBHP 2019 DUTHEIL 2
- Other IDs
- 2019-A02961-56
- Acronym
- JOBSTRESS
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dutheil F, Marhar F, Boudet G, Perrier C, Naughton G, Chamoux A, Huguet P, Mermillod M, Saadaoui F, Moustafa F, Schmidt J. Maximal tachycardia and high cardiac strain during night shifts of emergency physicians. Int Arch Occup Environ Health. 2017 Aug;90(6):467-480. doi: 10.1007/s00420-017-1211-5. Epub 2017 Mar 7.
PubMed 28271382
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
- ClinicalTrials.gov ID
- NCT04334083
- Acronym / sponsor ID
- JOBSTRESS / RBHP 2019 DUTHEIL 2
- Conditions
- Heart Rate Variability
- Keywords
- Heart rate variability, stress, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 6 Apr 2020 (actual)
- 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 medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Consequently, stress may lead to symptoms of mental exhaustion, physical fatigue, detachment from work, and feelings of diminished competence . Emergency physicians (EPs) are exposed to a complex interplay between stress (life-and-death emergencies - a defining characteristic of their job), sleep deprivation, and fatigue due to repeated changes in, and duration of shifts. Work-related exhaustion can lead to various physical and psychological symptoms, and also may be associated with delayed decision-making . The combined effects of stress and fatigue can impact on job performance, often resulting in otherwise preventable medical errors. Moreover, prolonged stress may expose EPs to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease. All these contribute to the premature departure of EPs to other specialties. Furthermore, low HRV has been associated with stress, burnout, and is linked with an increased risk of cardiovascular diseases.
This project proposes to evaluate if life-and-death emergencies or specific situations will induce abrupt changes in HRV among emergency physicians. Moreover, we would like to compare reactions between being an actor (EPs) and being a spectator and assess the role of expertise and habituation to stressful emergency situations.
Detailed description
The JOBSTRESS protocol was designed to provide a better understanding of the association between specific situations (ie: life and death emergencies) and breaks in the variability of the heart rate. Each emergency physician participates in the study two times. A night shift from 6:30 p.m to 8:30 a.m (14 hours) which will be compared with a day shift, as a control, from 8:30 a.m to 6:30 p.m. Emergency physicians will be accompanied by a medical externship student.
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be bilateral and a p <0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, average, median, standard deviation, and range. Graphic representations will be complete presentations of results. We process multivariate physiological series (HR, HRV, SC, wrist motion, respiratory rate) in order to build a stress index. For such multivariate physiological series, we first use change point analysis on each univariate series in order to get clusters with constant parameters, then we use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, we obtain at each time the level of stress and can compare it to the environmental conditions.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency physicians | Experimental | Behavioral: Comparison of biomarkers of stressactors during the work |
| medical externship student | Experimental | Behavioral: Comparison of biomarkers of stressspectator during the emergency physician work |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency physicians from the emergency department of CHU Clermont-Ferrand will be accompanied by a medical externship student.
- Ability to give a written informed consent.
Key exclusion criteria (1 listed)
- Participant refusal to participate
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 |
|---|---|---|
| Comparison of biomarkers of stressEmergency will be followed during a night shift and the rest day et during a day shift and the rest day. They will be observed by a medical externship student. We will assess the role of expertise and habituation to stressful emergency situations. | Behavioural | Emergency physicians, medical externship student |
Primary outcome
heart rate variability at night work
Time frame: from 18:30 to 8:30, during the 14 hours of the night shift
measure of abrupt changes in HRV signals during 14 hours
heart rate variability at day work
Time frame: from 8:30 to 18:30, during the 10 hours of the day shift
measure of abrupt changes in HRV signals during 10 hours
67 secondary outcomes
Stress
Time frame: 18:30, baseline of the night shift
Fatigue
Time frame: at 18:30, baseline of the night shift
Stress
Time frame: at 8h30, at the end of the night shift
Fatigue
Time frame: at 8:30, at the end of the night shift
Stress
Time frame: at 8:30, 24 hours after the end of night shift
Fatigue
Time frame: at 8:30, 24 hours after the end of night shift
Fatigue
Time frame: at 18:30, 24 hours after the end of day shift
Stress
Time frame: at 18:30, 24 hours after the end of day shift
Stress
Time frame: at 8:30, baseline of the day shift
Fatigue
Time frame: at 8:30, baseline of the day shift
Stress
Time frame: at 18:30, end of the day shift
Fatigue
Time frame: at 18:30, end of the day shift
Saliva biomarkers cortisol
Time frame: at 18:30, baseline of the night shift
Saliva biomarkers cortisol
Time frame: at 8:30, at the end of the night shift
Saliva biomarkers cortisol
Time frame: at 8:30, baseline of the day shift
Saliva biomarkers cortisol
Time frame: at 18:30, end of the day shift
Saliva biomarkers DHEAS
Time frame: at 18:30, baseline of the night shift
Saliva biomarkers DHEAS
Time frame: at 8:30, at the end of the night shift
Saliva biomarkers DHEAS
Time frame: at 8:30, baseline of the day shift
Saliva biomarkers DHEAS
Time frame: at 18:30, end of the day shift
Saliva biomarkers lgAs
Time frame: at 18:30, baseline of the night shift
Saliva biomarkers lgAs
Time frame: at 8:30, at the end of the night shift
Saliva biomarkers lgAs
Time frame: at 8:30, baseline of the day shift
Saliva biomarkers lgAs
Time frame: at 18:30, end of the day shift
blood samples full blood count
Time frame: at 8:30, at the end of the night shift
blood samples full blood count
Time frame: at 8:30, baseline of the day shift
blood samples HbA1c,
Time frame: at 8:30, at the end of the night shift
blood samples HbA1c,
Time frame: at 8:30, baseline of the day shift
blood samples HDLc and LDL-cholesterol
Time frame: at 8:30, at the end of the night shift
blood samples HDLc and LDL-cholesterol
Time frame: at 8:30, baseline of the day shift
blood samples TG
Time frame: at 8:30, at the end of the night shift
blood samples TG
Time frame: at 8:30, baseline of the day shift
blood samples Cortisol
Time frame: at 8:30, at the end of the night shift
blood samples Cortisol
Time frame: at 8:30, baseline of the day shift
blood samples DHEAS
Time frame: at 8:30, at the end of the night shift
blood samples DHEAS
Time frame: at 8:30, baseline of the day shift
blood samples vitamine D
Time frame: at 8:30, at the end of the night shift
blood samples vitamine D
Time frame: at 8:30, baseline of the day shift
blood samples BDNF
Time frame: at 8:30, at the end of the night shift
blood samples BDNF
Time frame: at 8:30, baseline of the day shift
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 28271382Dutheil F, Marhar F, Boudet G, Perrier C, Naughton G, Chamoux A, Huguet P, Mermillod M, Saadaoui F, Moustafa F, Schmidt J. Maximal tachycardia and high cardiac strain during night shifts of emergency physicians. Int Arch Occup Environ Health. 2017 Aug;90(6):467-480. doi: 10.1007/s00420-017-1211-5. Epub 2017 Mar 7.
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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.
Frédéric 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?
A study testing Comparison of biomarkers of stress in people with Heart Rate Variability, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability at night work (time frame: from 18:30 to 8:30, during the 14 hours of the night shift). The study lists 2 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 NCT04334083, 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 7 Aug 2026.