JOBSTRESS: Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT04334083
Collaborator
(none)
60
1
3
23.5
2.6

Study Details

Study Description

Brief 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. 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. We will further assess the role of expertise and habituation to stressful emergency situations between two untrained external observers

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Comparison of biomarkers of stress
N/A

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 four 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, 16 hours following the night shift and 14 hours following the day shift. Emergency physicians will be accompanied by a medical externship student and by a student in psychology.

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Actual Study Start Date :
Feb 17, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Emergency physicians

actors during the work

Behavioral: Comparison of biomarkers of stress
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 student (psychology student or medical externship student). We will assess the role of expertise and habituation to stressful emergency situations between two untrained external observers

Experimental: medical externship student

spectator during the emergency physician work

Behavioral: Comparison of biomarkers of stress
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 student (psychology student or medical externship student). We will assess the role of expertise and habituation to stressful emergency situations between two untrained external observers

Experimental: psychology student

spectator during the emergency physician work

Behavioral: Comparison of biomarkers of stress
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 student (psychology student or medical externship student). We will assess the role of expertise and habituation to stressful emergency situations between two untrained external observers

Outcome Measures

Primary Outcome Measures

  1. heart rate variability at night work [during 38 hours night 1]

    measure of abrupt changes in HRV signals during 38 hours

  2. heart rate variability at night work [during 38 hours night 2]

    measure of abrupt changes in HRV signals during 38 hours

  3. heart rate variability at day work [during 24 hours day 1]

    measure of abrupt changes in HRV signals during 24 hours

  4. heart rate variability at day work [during 24 hours day 2]

    measure of abrupt changes in HRV signals during 24 hours

Secondary Outcome Measures

  1. Stress [10 hours before the night 1 procedure]

    measure of stress using VAS

  2. Stress [10 hours before the night 2 procedure]

    measure of stress using VAS

  3. fatigue [10 hours before the night 1 procedure]

    measure of fatigue using VAS

  4. fatigue [10 hours before the night 2 procedure]

    measure of fatigue using VAS

  5. Stress [baseline of the night 1 procedure]

    measure of stress using VAS

  6. Stress [baseline of the night 2 procedure]

    measure of stress using VAS

  7. Fatigue [baseline of the night 1 procedure]

    measure of Fatigue using VAS

  8. Fatigue [baseline of the night 2 procedure]

    measure of Fatigue using VAS

  9. Stress [at the end of the night 1 procedure]

    measure of stress using VAS

  10. Fatigue [at the end of the night 2 procedure]

    measure of Fatigue using VAS

  11. Stress [10 hours after the end of the night 1 procedure]

    measure of stress using VAS

  12. Stress [10 hours after the end of the night 2 procedure]

    measure of stress using VAS

  13. Fatigue [10 hours after the end of the night 1 procedure]

    measure of Fatigue using VAS

  14. Fatigue [10 hours after the end of the night 2 procedure]

    measure of Fatigue using VAS

  15. Stress [24 hours after the end of the night 1 procedure]

    measure of stress using VAS

  16. Stress [24 hours after the end of the night 2 procedure]

    measure of stress using VAS

  17. Fatigue [24 hours after the end of the night 1 procedure]

    measure of Fatigue using VAS

  18. Fatigue [24 hours after the end of the night 2 procedure]

    measure of Fatigue using VAS

  19. Stress [baseline of the day 1 procedure]

    measure of stress using VAS

  20. Stress [baseline of the day 2 procedure]

    measure of stress using VAS

  21. Fatigue [baseline of the day 1 procedure]

    measure of Fatigue using VAS

  22. Fatigue [baseline of the day 2 procedure]

    measure of Fatigue using VAS

  23. Stress [end of the day 1 procedure]

    measure of stress using VAS

  24. Fatigue [end of the day 2 procedure]

    measure of Fatigue using VAS

  25. Stress [14 hours after the end of the day 1 procedure]

    measure of stress using VAS

  26. Stress [14 hours after the end of the day 2 procedure]

    measure of stress using VAS

  27. Fatigue [14 hours after the end of the day 1 procedure]

    measure of Fatigue using VAS

  28. Fatigue [14 hours after the end of the day 2 procedure]

    measure of Fatigue using VAS

  29. Saliva biomarkers cortisol [10 hours before the beginning of the night 1 procedure]

    measur of Cortisol

  30. Saliva biomarkers cortisol [10 hours before the beginning of the night 2 procedure]

    measur of Cortisol

  31. Saliva biomarkers cortisol [baseline of night 1 procedure]

    measur of Cortisol

  32. Saliva biomarkers cortisol [baseline of night 2 procedure]

    measur of Cortisol

  33. Saliva biomarkers cortisol [end of the night 1 procedure]

    measur of Cortisol

  34. Saliva biomarkers cortisol [end of the night 2 procedure]

    measur of Cortisol

  35. Saliva biomarkers cortisol [10 hours after the end of the night 1 procedure]

    measur of Cortisol

  36. Saliva biomarkers cortisol [10 hours after the end of the night 2 procedure]

    measur of Cortisol

  37. Saliva biomarkers cortisol [24 hours after the end of the night 1 procedure]

    measur of Cortisol

  38. Saliva biomarkers cortisol [24 hours after the end of the night 2 procedure]

    measur of Cortisol

  39. Saliva biomarkers cortisol [baseline of the day 1 procedure]

    measur of Cortisol

  40. Saliva biomarkers cortisol [baseline of the day 2 procedure]

    measur of Cortisol

  41. Saliva biomarkers cortisol [end of the day 1 procedure]

    measure of Cortisol

  42. Saliva biomarkers cortisol [end of the day 2 procedure]

    measure of Cortisol

  43. Saliva biomarkers cortisol [14 hours after the end of the day 1 procedure]

    measure of Cortisol

  44. Saliva biomarkers cortisol [14 hours after the end of the day 2 procedure]

    measure of Cortisol

  45. Saliva biomarkers DHEAS [10 hours before the beginning of the night 1 procedure]

    measure of DHEAS

  46. Saliva biomarkers DHEAS [10 hours before the beginning of the night 2 procedure]

    measure of DHEAS

  47. Saliva biomarkers DHEAS [baseline of the night 1 procedure]

    measure of DHEAS

  48. Saliva biomarkers DHEAS [baseline of the night 2 procedure]

    measure of DHEAS

  49. Saliva biomarkers DHEAS [end of the night 1 procedure]

    measure of DHEAS

  50. Saliva biomarkers DHEAS [end of the night 2 procedure]

    measure of DHEAS

  51. Saliva DHEAS [10 hours after the end of the night 1 procedure]

    measure of DHEAS

  52. Saliva DHEAS [10 hours after the end of the night 2 procedure]

    measure of DHEAS

  53. Saliva biomarkers DHEAS [24 hours after the end of the night 1 procedure]

    measure of DHEAS

  54. Saliva biomarkers DHEAS [24 hours after the end of the night 2 procedure]

    measure of DHEAS

  55. Saliva biomarkers DHEAS [baseline of the day 1 procedure]

    measure of DHEAS

  56. Saliva biomarkers DHEAS [baseline of the day 2 procedure]

    measure of DHEAS

  57. Saliva biomarkers DHEAS [14 hours after the end of the day 1 procedure]

    measure of DHEAS

  58. Saliva biomarkers DHEAS [14 hours after the end of the day 2 procedure]

    measure of DHEAS

  59. Saliva biomarkers lgAs [10 hours before the beginning of the night 1 procedure]

    measure of lgAs

  60. Saliva biomarkers lgAs [10 hours before the beginning of the night 2 procedure]

    measure of lgAs

  61. Saliva biomarkers lgAs [baseline of the night 1 procedure]

    measure of lgAs

  62. Saliva biomarkers lgAs [baseline of the night 2 procedure]

    measure of lgAs

  63. Saliva biomarkers lgAs [end of the night 1 procedure]

    measure of lgAs

  64. Saliva biomarkers lgAs [end of the night 2 procedure]

    measure of lgAs

  65. Saliva biomarkers lgAs [10 hours after the end of the night 1 procedure]

    measure of lgAs

  66. Saliva biomarkers lgAs [10 hours after the end of the night 2 procedure]

    measure of lgAs

  67. Saliva biomarkers lgAs [24 hours after the end of the night 1 procedure]

    measure of lgAs

  68. Saliva biomarkers lgAs [24 hours after the end of the night 2 procedure]

    measure of lgAs

  69. Saliva biomarkers lgAs [baseline of the day 1 procedure]

    measure of lgAs

  70. Saliva biomarkers lgAs [baseline of the day 2 procedure]

    measure of lgAs

  71. Saliva biomarkers lgAs [end of the day 1 procedure]

    measure of lgAs

  72. Saliva biomarkers lgAs [end of the day 2 procedure]

    measure of lgAs

  73. Saliva biomarkers lgAs [14 hours after the end of the day 1 procedure]

    measure of lgAs

  74. Saliva biomarkers lgAs [14 hours after the end of the day 2 procedure]

    measure of lgAs

  75. blood samples full blood count [end of night 1 procedure]

    : measure of full blood count

  76. blood samples full blood count [end of night 2 procedure]

    : measure of full blood count

  77. blood samples full blood count [baseline of day 1 procedure]

    : measure of full blood count

  78. blood samples full blood count [baseline of day 2 procedure]

    : measure of full blood count

  79. blood samples HbA1c, [end of night 1 procedure]

    : measure of HbA1c,

  80. blood samples HbA1c, [end of night 2 procedure]

    : measure of HbA1c,

  81. blood samples HbA1c [baseline of day 1 procedure]

    : measure of HbA1c

  82. blood samples HbA1c [baseline of day 2 procedure]

    : measure of HbA1c

  83. blood samples HDLc and LDL-cholesterol [end of the night 1 procedure]

    : measure of HDLc and LDL-cholesterol

  84. blood samples HDLc and LDL-cholesterol [end of the night 2 procedure]

    : measure of HDLc and LDL-cholesterol

  85. blood samples HDLc and LDL-cholesterol [baseline of the day 1 procedure]

    : measure of HDLc and LDL-cholesterol

  86. blood samples HDLc and LDL-cholesterol [baseline of the day 2 procedure]

    : measure of HDLc and LDL-cholesterol

  87. blood samples TG [end of the night 1 procedure]

    : measure of TG

  88. blood samples TG [end of the night 2 procedure]

    : measure of TG

  89. blood samples TG [baseline of the day 1 procedure]

    : measure of TG

  90. blood samples TG [baseline of the day 2 procedure]

    : measure of TG

  91. blood samples Cortisol [end of the night 1 procedure]

    : measure of Cortisol

  92. blood samples Cortisol [end of the night 2 procedure]

    : measure of Cortisol

  93. blood samples Cortisol [baseline of the day 1 procedure]

    : measure of Cortisol

  94. blood samples Cortisol [baseline of the day 2 procedure]

    : measure of Cortisol

  95. blood samples DHEAS [end of the night 1 procedure]

    : measure of DHEAS

  96. blood samples DHEAS [end of the night 2 procedure]

    : measure of DHEAS

  97. blood samples DHEAS [baseline of the day 1 procedure]

    : measure of DHEAS

  98. blood samples DHEAS [baseline of the day 2 procedure]

    : measure of DHEAS

  99. blood samples vitamine D [end of the night 1 procedure]

    : measure of vitamine D

  100. blood samples vitamine D [end of the night 2 procedure]

    : measure of vitamine D

  101. blood samples vitamine D [baseline of the day 1 procedure]

    : measure of vitamine D

  102. blood samples vitamine D [baseline of the day 2 procedure]

    : measure of vitamine D

  103. blood samples BDNF [end of the night 1 procedure]

    : measure of BDNF

  104. blood samples BDNF [end of the night 2 procedure]

    : measure of BDNF

  105. blood samples BDNF [baseline of the day 1 procedure]

    : measure of BDNF

  106. blood samples BDNF [baseline of the day 2 procedure]

    : measure of BDNF

  107. blood samples proinflammatory cytokines [end of the night 1 procedure]

    : measure of proinflammatory cytokines

  108. blood samples proinflammatory cytokines [end of the night 2 procedure]

    : measure of proinflammatory cytokines

  109. blood samples proinflammatory cytokines [baseline of the day 1 procedure]

    : measure of proinflammatory cytokines

  110. blood samples proinflammatory cytokines [baseline of the day 2 procedure]

    : measure of proinflammatory cytokines

  111. blood samples telomeres lengh [end of the night 1 procedure]

    : measure of telomeres lengh

  112. blood samples telomeres lengh [end of the night 2 procedure]

    : measure of telomeres lengh

  113. blood samples telomeres lengh [baseline of the day 1 procedure]

    : measure of telomeres lengh

  114. blood samples telomeres lengh [baseline of the day 2 procedure]

    : measure of telomeres lengh

  115. Mindfulness [day 1]

    Mindfulness is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)

  116. Burnout [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".

  117. Depression [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".

  118. Anxiety [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".

  119. General health [day 1]

    general health is assessed by the short form 36 health survey (SF36) composed by 36 items

  120. quality of life [day 1]

    quality of life is assessed by a brief multidimensional life satisfaction scale

  121. Personal resources [day 1]

    measure of trait perception of workplace stress (ICPH)

  122. Lifestyle [day 1]

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

  123. Physical activity [day 1]

    Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)

  124. Life and occupational events [day 1]

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

  125. Sick leave [day 1]

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

  126. Clinical measurements height [day 1]

    measure of height

  127. Clinical measurements weight [day 1]

    measure of weight

  128. Clinical measurements waist circumference [day 1]

    measure of waist circumference

  129. diastolic blood pressure [baseline of night 1 procedure]

    measure of diastolic blood pressure

  130. diastolic blood pressure [baseline of night 2 procedure]

    measure of diastolic blood pressure

  131. systolic blood pressure [baseline of night 1 procedure]

    measure of systolic blood pressure

  132. systolic blood pressure [baseline of night 2 procedure]

    measure of systolic blood pressure

  133. diastolic blood pressure [end of night 1 procedure]

    measure of diastolic blood pressure

  134. diastolic blood pressure [end of night 2 procedure]

    measure of diastolic blood pressure

  135. systolic blood pressure [end of night 1 procedure]

    measure of systolic blood pressure

  136. systolic blood pressure [end of night 2 procedure]

    measure of systolic blood pressure

  137. diastolic blood pressure [baseline of day 1 procedure]

    measure of disatolic blood pressure

  138. diastolic blood pressure [baseline of day 2 procedure]

    measure of disatolic blood pressure

  139. systolic blood pressure [baseline of day 1 procedure]

    measure of systolic blood pressure

  140. systolic blood pressure [baseline of day 2 procedure]

    measure of systolic blood pressure

  141. diastolic blood pressure [end of day 1 procedure]

    measure of disatolic blood pressure

  142. diastolic blood pressure [end of day 2 procedure]

    measure of disatolic blood pressure

  143. systolic blood pressure [end of day 1 procedure]

    measure of systolic blood pressure

  144. systolic blood pressure [end of day 2 procedure]

    measure of systolic blood pressure

  145. skin conductance [during 38 hours of night 1 procedure]

    measure of the skin conductance

  146. skin conductance [during 38 hours of night 2 procedure]

    measure of the skin conductance

  147. skin conductance [during 24 hours of day 1 procedure]

    measure of the skin conductance

  148. skin conductance [during 24 hours of day 2 procedure]

    measure of the skin conductance

  149. Genetic factors ACE [end of the night 1 procedure]

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  150. Genetic factors ACE [end of the night 2 procedure]

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  151. Genetic factors ACE [baseline of the day 1 procedure]

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  152. Genetic factors ACE [baseline of the day 2 procedure]

    measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE

  153. Genetic factors (5-HTT) [end of the night 1 procedure]

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

  154. Genetic factors (5-HTT) [end of the night 2 procedure]

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

  155. Genetic factors (5-HTT) [baseline of the day 1 procedure]

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

  156. Genetic factors (5-HTT) [baseline of the day 2 procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Emergency physicians from the emergency department of CHU Clermont-Ferrand will be accompanied by a medical externship student and by a student in psychology.

  • Ability to give a written informed consent.

Exclusion Criteria:
  • Participant refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Clermont Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frédéric Dutheil, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT04334083
Other Study ID Numbers:
  • RBHP 2019 DUTHEIL 2
  • 2019-A02961-56
First Posted:
Apr 6, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022