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

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate Variability
• Intervention / Treatment: Behavioral: Comparison of biomarkers of stress

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 medical externship student. We will assess the role of expertise and habituation to stressful emergency situations.
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 medical externship student. We will assess the role of expertise and habituation to stressful emergency situations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability at night work	measure of abrupt changes in HRV signals during 14 hours	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	from 8:30 to 18:30, during the 10 hours of the day shift

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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".	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".	day 1
Lifestyle	Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).	day 1
Life and occupational events	Assessing factors regarding death of patients or death of a loved one by questionnaire.	day 1
Sick leave	assessing sick leave by the number of absence days the previous 6 months using a questionnaire	day 1
Clinical measurements height	measure of height	day 1
Clinical measurements weight	measure of weight	day 1
Stress	measure of stress using VAS	18:30, baseline of the night shift
Fatigue	measure of Fatigue using VAS	at 18:30, baseline of the night shift
Stress	measure of stress using VAS	at 8h30, at the end of the night shift
Fatigue	measure of Fatigue using VAS	at 8:30, at the end of the night shift
Stress	measure of stress using VAS	at 8:30, 24 hours after the end of night shift
Fatigue	measure of Fatigue using VAS	at 8:30, 24 hours after the end of night shift
Fatigue	measure of Fatigue using VAS	at 18:30, 24 hours after the end of day shift
Stress	measure of stress using VAS	at 18:30, 24 hours after the end of day shift
Stress	measure of stress using VAS	at 8:30, baseline of the day shift
Fatigue	measure of Fatigue using VAS	at 8:30, baseline of the day shift
Stress	measure of stress using VAS	at 18:30, end of the day shift
Fatigue	measure of Fatigue using VAS	at 18:30, end of the day shift
Saliva biomarkers cortisol	measure of Cortisol	at 18:30, baseline of the night shift
Saliva biomarkers cortisol	measure of Cortisol	at 8:30, at the end of the night shift
Saliva biomarkers cortisol	measure of Cortisol	at 8:30, baseline of the day shift
Saliva biomarkers cortisol	measure of Cortisol	at 18:30, end of the day shift
Saliva biomarkers DHEAS	measure of DHEAS	at 18:30, baseline of the night shift
Saliva biomarkers DHEAS	measure of DHEAS	at 8:30, at the end of the night shift
Saliva biomarkers DHEAS	measure of DHEAS	at 8:30, baseline of the day shift
Saliva biomarkers DHEAS	measure of DHEAS	at 18:30, end of the day shift
Saliva biomarkers lgAs	measure of lgAs	at 18:30, baseline of the night shift
Saliva biomarkers lgAs	measure of lgAs	at 8:30, at the end of the night shift
Saliva biomarkers lgAs	measure of lgAs	at 8:30, baseline of the day shift
Saliva biomarkers lgAs	measure of lgAs	at 18:30, end of the day shift
blood samples full blood count	measure of full blood count	at 8:30, at the end of the night shift
blood samples full blood count	measure of full blood count	at 8:30, baseline of the day shift
blood samples HbA1c,	measure of HbA1c	at 8:30, at the end of the night shift
blood samples HbA1c,	measure of HbA1c	at 8:30, baseline of the day shift
blood samples HDLc and LDL-cholesterol	measure of HDLc and LDL-cholesterol	at 8:30, at the end of the night shift
blood samples HDLc and LDL-cholesterol	measure of HDLc and LDL-cholesterol	at 8:30, baseline of the day shift
blood samples TG	measure of TG	at 8:30, at the end of the night shift
blood samples TG	measure of TG	at 8:30, baseline of the day shift
blood samples Cortisol	measure of Cortisol	at 8:30, at the end of the night shift
blood samples Cortisol	measure of Cortisol	at 8:30, baseline of the day shift
blood samples DHEAS	measure of DHEAS	at 8:30, at the end of the night shift
blood samples DHEAS	measure of DHEAS	at 8:30, baseline of the day shift
blood samples vitamine D	measure of vitamine D	at 8:30, at the end of the night shift
blood samples vitamine D	measure of vitamine D	at 8:30, baseline of the day shift
blood samples BDNF	measure of BDNF	at 8:30, at the end of the night shift
blood samples BDNF	measure of BDNF	at 8:30, baseline of the day shift
blood samples proinflammatory cytokines	measure of proinflammatory cytokines	at 8:30, at the end of the night shift
blood samples proinflammatory cytokines	measure of proinflammatory cytokines	at 8:30, baseline of the day shift
blood samples telomeres lengh	measure of telomeres lengh	at 8:30, at the end of the night shift
blood samples telomeres lengh	measure of telomeres lengh	at 8:30, baseline of the day shift
Life satisfaction	quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)	day 1
diastolic blood pressure	measure of diastolic blood pressure	at 18:30, baseline of the night shift
systolic blood pressure	measure of systolic blood pressure	at 18:30, baseline of the night shift
diastolic blood pressure	measure of diastolic blood pressure	at 8:30, at the end of the night shift
systolic blood pressure	measure of systolic blood pressure	at 8:30, at the end of the night shift
diastolic blood pressure	measure of disatolic blood pressure	at 8:30, baseline of the day shift
systolic blood pressure	measure of systolic blood pressure	at 8:30, baseline of the day shift
diastolic blood pressure	measure of disatolic blood pressure	at 18:30, end of day shift
systolic blood pressure	measure of systolic blood pressure	at 18:30, end of day shift
skin conductance	measure of the skin conductance	from 18:30 to 8:30, during the 14 hours of night shift
skin conductance	measure of the skin conductance	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	at 8:30, end of the night shift
Genetic factors ACE	measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE	at 8:30, baseline of the day shift
Genetic factors (5-HTT)	measure of the polymorphism of the serotonin transporter (5-HTT)	at 8:30, end of the night shift
Genetic factors (5-HTT)	measure of the polymorphism of the serotonin transporter (5-HTT)	at 8:30, baseline of the day shift

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: stress; cortisol; Heart rate variability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Stress, Psychological; Occupational Diseases; Emergencies; Occupational Stress
• Other Study ID Numbers: RBHP 2019 DUTHEIL 2; 2019-A02961-56 (Other Identifier: 2019-A02961-56)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No