Skip to main content
OpenTrials
Completed

NCT Number: NCT04334083

Biomarkes 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Rate Variability

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participant refusal to participate

Treatment and study plan

Comparison of biomarkers of stress

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Stress

    Time frame: 18:30, baseline of the night shift

    measure of stress using VAS

  2. Fatigue

    Time frame: at 18:30, baseline of the night shift

    measure of Fatigue using VAS

  3. Stress

    Time frame: at 8h30, at the end of the night shift

    measure of stress using VAS

  4. Fatigue

    Time frame: at 8:30, at the end of the night shift

    measure of Fatigue using VAS

  5. Stress

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

    measure of stress using VAS

  6. Fatigue

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

    measure of Fatigue using VAS

  7. Fatigue

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

    measure of Fatigue using VAS

  8. Stress

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

    measure of stress using VAS

  9. Stress

    Time frame: at 8:30, baseline of the day shift

    measure of stress using VAS

  10. Fatigue

    Time frame: at 8:30, baseline of the day shift

    measure of Fatigue using VAS

  11. Stress

    Time frame: at 18:30, end of the day shift

    measure of stress using VAS

  12. Fatigue

    Time frame: at 18:30, end of the day shift

    measure of Fatigue using VAS

  13. Saliva biomarkers cortisol

    Time frame: at 18:30, baseline of the night shift

    measure of Cortisol

  14. Saliva biomarkers cortisol

    Time frame: at 8:30, at the end of the night shift

    measure of Cortisol

  15. Saliva biomarkers cortisol

    Time frame: at 8:30, baseline of the day shift

    measure of Cortisol

  16. Saliva biomarkers cortisol

    Time frame: at 18:30, end of the day shift

    measure of Cortisol

  17. Saliva biomarkers DHEAS

    Time frame: at 18:30, baseline of the night shift

    measure of DHEAS

  18. Saliva biomarkers DHEAS

    Time frame: at 8:30, at the end of the night shift

    measure of DHEAS

  19. Saliva biomarkers DHEAS

    Time frame: at 8:30, baseline of the day shift

    measure of DHEAS

  20. Saliva biomarkers DHEAS

    Time frame: at 18:30, end of the day shift

    measure of DHEAS

  21. Saliva biomarkers lgAs

    Time frame: at 18:30, baseline of the night shift

    measure of lgAs

  22. Saliva biomarkers lgAs

    Time frame: at 8:30, at the end of the night shift

    measure of lgAs

  23. Saliva biomarkers lgAs

    Time frame: at 8:30, baseline of the day shift

    measure of lgAs

  24. Saliva biomarkers lgAs

    Time frame: at 18:30, end of the day shift

    measure of lgAs

  25. blood samples full blood count

    Time frame: at 8:30, at the end of the night shift

    measure of full blood count

  26. blood samples full blood count

    Time frame: at 8:30, baseline of the day shift

    measure of full blood count

  27. blood samples HbA1c,

    Time frame: at 8:30, at the end of the night shift

    measure of HbA1c

  28. blood samples HbA1c,

    Time frame: at 8:30, baseline of the day shift

    measure of HbA1c

  29. blood samples HDLc and LDL-cholesterol

    Time frame: at 8:30, at the end of the night shift

    measure of HDLc and LDL-cholesterol

  30. blood samples HDLc and LDL-cholesterol

    Time frame: at 8:30, baseline of the day shift

    measure of HDLc and LDL-cholesterol

  31. blood samples TG

    Time frame: at 8:30, at the end of the night shift

    measure of TG

  32. blood samples TG

    Time frame: at 8:30, baseline of the day shift

    measure of TG

  33. blood samples Cortisol

    Time frame: at 8:30, at the end of the night shift

    measure of Cortisol

  34. blood samples Cortisol

    Time frame: at 8:30, baseline of the day shift

    measure of Cortisol

  35. blood samples DHEAS

    Time frame: at 8:30, at the end of the night shift

    measure of DHEAS

  36. blood samples DHEAS

    Time frame: at 8:30, baseline of the day shift

    measure of DHEAS

  37. blood samples vitamine D

    Time frame: at 8:30, at the end of the night shift

    measure of vitamine D

  38. blood samples vitamine D

    Time frame: at 8:30, baseline of the day shift

    measure of vitamine D

  39. blood samples BDNF

    Time frame: at 8:30, at the end of the night shift

    measure of BDNF

  40. blood samples BDNF

    Time frame: at 8:30, baseline of the day shift

    measure of BDNF

  41. blood samples proinflammatory cytokines

    Time frame: at 8:30, at the end of the night shift

    measure of proinflammatory cytokines

  42. blood samples proinflammatory cytokines

    Time frame: at 8:30, baseline of the day shift

    measure of proinflammatory cytokines

  43. blood samples telomeres lengh

    Time frame: at 8:30, at the end of the night shift

    measure of telomeres lengh

  44. blood samples telomeres lengh

    Time frame: at 8:30, baseline of the day shift

    measure of telomeres lengh

  45. Burnout

    Time frame: day 1

    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".

  46. Depression

    Time frame: day 1

    depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".

  47. Anxiety

    Time frame: day 1

    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".

  48. Life satisfaction

    Time frame: day 1

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

  49. Lifestyle

    Time frame: day 1

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

  50. Life and occupational events

    Time frame: day 1

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

  51. Sick leave

    Time frame: day 1

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

  52. Clinical measurements height

    Time frame: day 1

    measure of height

  53. Clinical measurements weight

    Time frame: day 1

    measure of weight

  54. diastolic blood pressure

    Time frame: at 18:30, baseline of the night shift

    measure of diastolic blood pressure

  55. systolic blood pressure

    Time frame: at 18:30, baseline of the night shift

    measure of systolic blood pressure

  56. diastolic blood pressure

    Time frame: at 8:30, at the end of the night shift

    measure of diastolic blood pressure

  57. systolic blood pressure

    Time frame: at 8:30, at the end of the night shift

    measure of systolic blood pressure

  58. diastolic blood pressure

    Time frame: at 8:30, baseline of the day shift

    measure of disatolic blood pressure

  59. systolic blood pressure

    Time frame: at 8:30, baseline of the day shift

    measure of systolic blood pressure

  60. diastolic blood pressure

    Time frame: at 18:30, end of day shift

    measure of disatolic blood pressure

  61. systolic blood pressure

    Time frame: at 18:30, end of day shift

    measure of systolic blood pressure

  62. skin conductance

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

    measure of the skin conductance

  63. skin conductance

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

    measure of the skin conductance

  64. Genetic factors ACE

    Time frame: at 8:30, end of the night shift

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  65. Genetic factors ACE

    Time frame: at 8:30, baseline of the day shift

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  66. Genetic factors (5-HTT)

    Time frame: at 8:30, end of the night shift

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

  67. Genetic factors (5-HTT)

    Time frame: at 8:30, baseline of the day shift

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events

Acronym: JOBSTRESS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2020
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.