AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

France1 site
  • Chu Clermont Ferrand

    Clermont-Ferrand, 63003

Other trials in France

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.

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 groups in NCT04334083
Study groupRoleWhat they receive
Emergency physiciansExperimentalactors during the work
Receives: Behavioral: Comparison of biomarkers of stress
medical externship studentExperimentalspectator 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.

  1. 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

  2. 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)
  1. Stress

    measure of stress using VAS

    Measured: 18:30, baseline of the night shift

  2. Fatigue

    measure of Fatigue using VAS

    Measured: at 18:30, baseline of the night shift

  3. Stress

    measure of stress using VAS

    Measured: at 8h30, at the end of the night shift

  4. Fatigue

    measure of Fatigue using VAS

    Measured: at 8:30, at the end of the night shift

  5. Stress

    measure of stress using VAS

    Measured: at 8:30, 24 hours after the end of night shift

  6. Fatigue

    measure of Fatigue using VAS

    Measured: at 8:30, 24 hours after the end of night shift

  7. Fatigue

    measure of Fatigue using VAS

    Measured: at 18:30, 24 hours after the end of day shift

  8. Stress

    measure of stress using VAS

    Measured: at 18:30, 24 hours after the end of day shift

  9. Stress

    measure of stress using VAS

    Measured: at 8:30, baseline of the day shift

  10. Fatigue

    measure of Fatigue using VAS

    Measured: at 8:30, baseline of the day shift

  11. Stress

    measure of stress using VAS

    Measured: at 18:30, end of the day shift

  12. Fatigue

    measure of Fatigue using VAS

    Measured: at 18:30, end of the day shift

  13. Saliva biomarkers cortisol

    measure of Cortisol

    Measured: at 18:30, baseline of the night shift

  14. Saliva biomarkers cortisol

    measure of Cortisol

    Measured: at 8:30, at the end of the night shift

  15. Saliva biomarkers cortisol

    measure of Cortisol

    Measured: at 8:30, baseline of the day shift

  16. Saliva biomarkers cortisol

    measure of Cortisol

    Measured: at 18:30, end of the day shift

  17. Saliva biomarkers DHEAS

    measure of DHEAS

    Measured: at 18:30, baseline of the night shift

  18. Saliva biomarkers DHEAS

    measure of DHEAS

    Measured: at 8:30, at the end of the night shift

  19. Saliva biomarkers DHEAS

    measure of DHEAS

    Measured: at 8:30, baseline of the day shift

  20. Saliva biomarkers DHEAS

    measure of DHEAS

    Measured: at 18:30, end of the day shift

  21. Saliva biomarkers lgAs

    measure of lgAs

    Measured: at 18:30, baseline of the night shift

  22. Saliva biomarkers lgAs

    measure of lgAs

    Measured: at 8:30, at the end of the night shift

  23. Saliva biomarkers lgAs

    measure of lgAs

    Measured: at 8:30, baseline of the day shift

  24. Saliva biomarkers lgAs

    measure of lgAs

    Measured: at 18:30, end of the day shift

  25. blood samples full blood count

    measure of full blood count

    Measured: at 8:30, at the end of the night shift

  26. blood samples full blood count

    measure of full blood count

    Measured: at 8:30, baseline of the day shift

  27. blood samples HbA1c,

    measure of HbA1c

    Measured: at 8:30, at the end of the night shift

  28. blood samples HbA1c,

    measure of HbA1c

    Measured: at 8:30, baseline of the day shift

  29. blood samples HDLc and LDL-cholesterol

    measure of HDLc and LDL-cholesterol

    Measured: at 8:30, at the end of the night shift

  30. blood samples HDLc and LDL-cholesterol

    measure of HDLc and LDL-cholesterol

    Measured: at 8:30, baseline of the day shift

  31. blood samples TG

    measure of TG

    Measured: at 8:30, at the end of the night shift

  32. blood samples TG

    measure of TG

    Measured: at 8:30, baseline of the day shift

  33. blood samples Cortisol

    measure of Cortisol

    Measured: at 8:30, at the end of the night shift

  34. blood samples Cortisol

    measure of Cortisol

    Measured: at 8:30, baseline of the day shift

  35. blood samples DHEAS

    measure of DHEAS

    Measured: at 8:30, at the end of the night shift

  36. blood samples DHEAS

    measure of DHEAS

    Measured: at 8:30, baseline of the day shift

  37. blood samples vitamine D

    measure of vitamine D

    Measured: at 8:30, at the end of the night shift

  38. blood samples vitamine D

    measure of vitamine D

    Measured: at 8:30, baseline of the day shift

  39. blood samples BDNF

    measure of BDNF

    Measured: at 8:30, at the end of the night shift

  40. blood samples BDNF

    measure of BDNF

    Measured: at 8:30, baseline of the day shift

  41. blood samples proinflammatory cytokines

    measure of proinflammatory cytokines

    Measured: at 8:30, at the end of the night shift

  42. blood samples proinflammatory cytokines

    measure of proinflammatory cytokines

    Measured: at 8:30, baseline of the day shift

  43. blood samples telomeres lengh

    measure of telomeres lengh

    Measured: at 8:30, at the end of the night shift

  44. blood samples telomeres lengh

    measure of telomeres lengh

    Measured: at 8:30, baseline of the day shift

  45. 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

  46. 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

  47. 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

  48. Life satisfaction

    quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)

    Measured: day 1

  49. Lifestyle

    Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).

    Measured: day 1

  50. Life and occupational events

    Assessing factors regarding death of patients or death of a loved one by questionnaire.

    Measured: day 1

  51. Sick leave

    assessing sick leave by the number of absence days the previous 6 months using a questionnaire

    Measured: day 1

  52. Clinical measurements height

    measure of height

    Measured: day 1

  53. Clinical measurements weight

    measure of weight

    Measured: day 1

  54. diastolic blood pressure

    measure of diastolic blood pressure

    Measured: at 18:30, baseline of the night shift

  55. systolic blood pressure

    measure of systolic blood pressure

    Measured: at 18:30, baseline of the night shift

  56. diastolic blood pressure

    measure of diastolic blood pressure

    Measured: at 8:30, at the end of the night shift

  57. systolic blood pressure

    measure of systolic blood pressure

    Measured: at 8:30, at the end of the night shift

  58. diastolic blood pressure

    measure of disatolic blood pressure

    Measured: at 8:30, baseline of the day shift

  59. systolic blood pressure

    measure of systolic blood pressure

    Measured: at 8:30, baseline of the day shift

  60. diastolic blood pressure

    measure of disatolic blood pressure

    Measured: at 18:30, end of day shift

  61. systolic blood pressure

    measure of systolic blood pressure

    Measured: at 18:30, end of day shift

  62. skin conductance

    measure of the skin conductance

    Measured: from 18:30 to 8:30, during the 14 hours of night shift

  63. skin conductance

    measure of the skin conductance

    Measured: from 8:30 to 18:30, during the 10 hours of day shift

  64. Genetic factors ACE

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

    Measured: at 8:30, end of the night shift

  65. Genetic factors ACE

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

    Measured: at 8:30, baseline of the day shift

  66. Genetic factors (5-HTT)

    measure of the polymorphism of the serotonin transporter (5-HTT)

    Measured: at 8:30, end of the night shift

  67. 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.

  1. First posted6 Apr 2020
  2. Study start17 Feb 2022
  3. Primary completion21 Dec 2023
  4. Study completion21 Dec 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in