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

Heart Rate Variability Clinical Trial

— JOBSTRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334083
• Other study ID #: RBHP 2019 DUTHEIL 2
• Secondary ID: 2019-A02961-56
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Heart Rate Variability
• Occupational Stress

Intervention

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.

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Stress	measure of stress using VAS	18:30, baseline of the night shift
Secondary	Fatigue	measure of Fatigue using VAS	at 18:30, baseline of the night shift
Secondary	Stress	measure of stress using VAS	at 8h30, at the end of the night shift
Secondary	Fatigue	measure of Fatigue using VAS	at 8:30, at the end of the night shift
Secondary	Stress	measure of stress using VAS	at 8:30, 24 hours after the end of night shift
Secondary	Fatigue	measure of Fatigue using VAS	at 8:30, 24 hours after the end of night shift
Secondary	Fatigue	measure of Fatigue using VAS	at 18:30, 24 hours after the end of day shift
Secondary	Stress	measure of stress using VAS	at 18:30, 24 hours after the end of day shift
Secondary	Stress	measure of stress using VAS	at 8:30, baseline of the day shift
Secondary	Fatigue	measure of Fatigue using VAS	at 8:30, baseline of the day shift
Secondary	Stress	measure of stress using VAS	at 18:30, end of the day shift
Secondary	Fatigue	measure of Fatigue using VAS	at 18:30, end of the day shift
Secondary	Saliva biomarkers cortisol	measure of Cortisol	at 18:30, baseline of the night shift
Secondary	Saliva biomarkers cortisol	measure of Cortisol	at 8:30, at the end of the night shift
Secondary	Saliva biomarkers cortisol	measure of Cortisol	at 8:30, baseline of the day shift
Secondary	Saliva biomarkers cortisol	measure of Cortisol	at 18:30, end of the day shift
Secondary	Saliva biomarkers DHEAS	measure of DHEAS	at 18:30, baseline of the night shift
Secondary	Saliva biomarkers DHEAS	measure of DHEAS	at 8:30, at the end of the night shift
Secondary	Saliva biomarkers DHEAS	measure of DHEAS	at 8:30, baseline of the day shift
Secondary	Saliva biomarkers DHEAS	measure of DHEAS	at 18:30, end of the day shift
Secondary	Saliva biomarkers lgAs	measure of lgAs	at 18:30, baseline of the night shift
Secondary	Saliva biomarkers lgAs	measure of lgAs	at 8:30, at the end of the night shift
Secondary	Saliva biomarkers lgAs	measure of lgAs	at 8:30, baseline of the day shift
Secondary	Saliva biomarkers lgAs	measure of lgAs	at 18:30, end of the day shift
Secondary	blood samples full blood count	measure of full blood count	at 8:30, at the end of the night shift
Secondary	blood samples full blood count	measure of full blood count	at 8:30, baseline of the day shift
Secondary	blood samples HbA1c,	measure of HbA1c	at 8:30, at the end of the night shift
Secondary	blood samples HbA1c,	measure of HbA1c	at 8:30, baseline of the day shift
Secondary	blood samples HDLc and LDL-cholesterol	measure of HDLc and LDL-cholesterol	at 8:30, at the end of the night shift
Secondary	blood samples HDLc and LDL-cholesterol	measure of HDLc and LDL-cholesterol	at 8:30, baseline of the day shift
Secondary	blood samples TG	measure of TG	at 8:30, at the end of the night shift
Secondary	blood samples TG	measure of TG	at 8:30, baseline of the day shift
Secondary	blood samples Cortisol	measure of Cortisol	at 8:30, at the end of the night shift
Secondary	blood samples Cortisol	measure of Cortisol	at 8:30, baseline of the day shift
Secondary	blood samples DHEAS	measure of DHEAS	at 8:30, at the end of the night shift
Secondary	blood samples DHEAS	measure of DHEAS	at 8:30, baseline of the day shift
Secondary	blood samples vitamine D	measure of vitamine D	at 8:30, at the end of the night shift
Secondary	blood samples vitamine D	measure of vitamine D	at 8:30, baseline of the day shift
Secondary	blood samples BDNF	measure of BDNF	at 8:30, at the end of the night shift
Secondary	blood samples BDNF	measure of BDNF	at 8:30, baseline of the day shift
Secondary	blood samples proinflammatory cytokines	measure of proinflammatory cytokines	at 8:30, at the end of the night shift
Secondary	blood samples proinflammatory cytokines	measure of proinflammatory cytokines	at 8:30, baseline of the day shift
Secondary	blood samples telomeres lengh	measure of telomeres lengh	at 8:30, at the end of the night shift
Secondary	blood samples telomeres lengh	measure of telomeres lengh	at 8:30, baseline of the day shift
Secondary	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
Secondary	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
Secondary	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
Secondary	Life satisfaction	quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)	day 1
Secondary	Lifestyle	Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).	day 1
Secondary	Life and occupational events	Assessing factors regarding death of patients or death of a loved one by questionnaire.	day 1
Secondary	Sick leave	assessing sick leave by the number of absence days the previous 6 months using a questionnaire	day 1
Secondary	Clinical measurements height	measure of height	day 1
Secondary	Clinical measurements weight	measure of weight	day 1
Secondary	diastolic blood pressure	measure of diastolic blood pressure	at 18:30, baseline of the night shift
Secondary	systolic blood pressure	measure of systolic blood pressure	at 18:30, baseline of the night shift
Secondary	diastolic blood pressure	measure of diastolic blood pressure	at 8:30, at the end of the night shift
Secondary	systolic blood pressure	measure of systolic blood pressure	at 8:30, at the end of the night shift
Secondary	diastolic blood pressure	measure of disatolic blood pressure	at 8:30, baseline of the day shift
Secondary	systolic blood pressure	measure of systolic blood pressure	at 8:30, baseline of the day shift
Secondary	diastolic blood pressure	measure of disatolic blood pressure	at 18:30, end of day shift
Secondary	systolic blood pressure	measure of systolic blood pressure	at 18:30, end of day shift
Secondary	skin conductance	measure of the skin conductance	from 18:30 to 8:30, during the 14 hours of night shift
Secondary	skin conductance	measure of the skin conductance	from 8:30 to 18:30, during the 10 hours of day shift
Secondary	Genetic factors ACE	measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE	at 8:30, end of the night shift
Secondary	Genetic factors ACE	measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE	at 8:30, baseline of the day shift
Secondary	Genetic factors (5-HTT)	measure of the polymorphism of the serotonin transporter (5-HTT)	at 8:30, end of the night shift
Secondary	Genetic factors (5-HTT)	measure of the polymorphism of the serotonin transporter (5-HTT)	at 8:30, baseline of the day shift