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Clinical Trials/NCT04334083
NCT04334083
Completed
Not Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country48 target enrollmentFebruary 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Rate Variability
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
48
Locations
1
Primary Endpoint
heart rate variability at night work
Status
Completed
Last Updated
2 years ago

Overview

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 and assess the role of expertise and habituation to stressful emergency situations.

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2022
End Date
December 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

  • Fatigue(at 18:30, end of the day shift)
  • Saliva biomarkers DHEAS(at 18:30, end of the day shift)
  • blood samples TG(at 8:30, baseline of the day shift)
  • blood samples DHEAS(at 8:30, baseline of the day shift)
  • blood samples BDNF(at 8:30, baseline of the day shift)
  • blood samples proinflammatory cytokines(at 8:30, baseline of the day shift)
  • Burnout(day 1)
  • Sick leave(day 1)
  • blood samples HDLc and LDL-cholesterol(at 8:30, baseline of the day shift)
  • blood samples Cortisol(at 8:30, baseline of the day shift)
  • blood samples vitamine D(at 8:30, baseline of the day shift)
  • Stress(at 18:30, end of the day shift)
  • Saliva biomarkers cortisol(at 18:30, end of the day shift)
  • blood samples full blood count(at 8:30, baseline of the day shift)
  • blood samples HbA1c,(at 8:30, baseline of the day shift)
  • Saliva biomarkers lgAs(at 18:30, end of the day shift)
  • blood samples telomeres lengh(at 8:30, baseline of the day shift)
  • Anxiety(day 1)
  • Depression(day 1)
  • systolic blood pressure(at 18:30, end of day shift)
  • Life satisfaction(day 1)
  • Lifestyle(day 1)
  • Clinical measurements weight(day 1)
  • Clinical measurements height(day 1)
  • Life and occupational events(day 1)
  • diastolic blood pressure(at 18:30, end of day shift)
  • skin conductance(from 8:30 to 18:30, during the 10 hours of day shift)
  • Genetic factors ACE(at 8:30, baseline of the day shift)
  • Genetic factors (5-HTT)(at 8:30, baseline of the day shift)

Study Sites (1)

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