Clinical trial NCT04334083: Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Official title: Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Rate Variability
Keywords: Heart rate variability
stress
cortisol
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: heart rate variability at night work
timeFrame: from 18:30 to 8:30, during the 14 hours of the night shift
measure: heart rate variability at day work
timeFrame: from 8:30 to 18:30, during the 10 hours of the day shift
Secondary outcomes:
measure: Stress
timeFrame: 18:30, baseline of the night shift
measure: Fatigue
timeFrame: at 18:30, baseline of the night shift
measure: Stress
timeFrame: at 8h30, at the end of the night shift
measure: Fatigue
timeFrame: at 8:30, at the end of the night shift
measure: Stress
timeFrame: at 8:30, 24 hours after the end of night shift
measure: Fatigue
timeFrame: at 8:30, 24 hours after the end of night shift
measure: Fatigue
timeFrame: at 18:30, 24 hours after the end of day shift
measure: Stress
timeFrame: at 18:30, 24 hours after the end of day shift
measure: Stress
timeFrame: at 8:30, baseline of the day shift
measure: Fatigue
timeFrame: at 8:30, baseline of the day shift
measure: Stress
timeFrame: at 18:30, end of the day shift
measure: Fatigue
timeFrame: at 18:30, end of the day shift
measure: Saliva biomarkers cortisol
timeFrame: at 18:30, baseline of the night shift
measure: Saliva biomarkers cortisol
timeFrame: at 8:30, at the end of the night shift
measure: Saliva biomarkers cortisol
timeFrame: at 8:30, baseline of the day shift
measure: Saliva biomarkers cortisol
timeFrame: at 18:30, end of the day shift
measure: Saliva biomarkers DHEAS
timeFrame: at 18:30, baseline of the night shift
measure: Saliva biomarkers DHEAS
timeFrame: at 8:30, at the end of the night shift
measure: Saliva biomarkers DHEAS
timeFrame: at 8:30, baseline of the day shift
measure: Saliva biomarkers DHEAS
timeFrame: at 18:30, end of the day shift
measure: Saliva biomarkers lgAs
timeFrame: at 18:30, baseline of the night shift
measure: Saliva biomarkers lgAs
timeFrame: at 8:30, at the end of the night shift
measure: Saliva biomarkers lgAs
timeFrame: at 8:30, baseline of the day shift
measure: Saliva biomarkers lgAs
timeFrame: at 18:30, end of the day shift
measure: blood samples full blood count
timeFrame: at 8:30, at the end of the night shift
measure: blood samples full blood count
timeFrame: at 8:30, baseline of the day shift
measure: blood samples HbA1c,
timeFrame: at 8:30, at the end of the night shift
measure: blood samples HbA1c,
timeFrame: at 8:30, baseline of the day shift
measure: blood samples HDLc and LDL-cholesterol
timeFrame: at 8:30, at the end of the night shift
measure: blood samples HDLc and LDL-cholesterol
timeFrame: at 8:30, baseline of the day shift
measure: blood samples TG
timeFrame: at 8:30, at the end of the night shift
measure: blood samples TG
timeFrame: at 8:30, baseline of the day shift
measure: blood samples Cortisol
timeFrame: at 8:30, at the end of the night shift
measure: blood samples Cortisol
timeFrame: at 8:30, baseline of the day shift
measure: blood samples DHEAS
timeFrame: at 8:30, at the end of the night shift
measure: blood samples DHEAS
timeFrame: at 8:30, baseline of the day shift
measure: blood samples vitamine D
timeFrame: at 8:30, at the end of the night shift
measure: blood samples vitamine D
timeFrame: at 8:30, baseline of the day shift
measure: blood samples BDNF
timeFrame: at 8:30, at the end of the night shift
measure: blood samples BDNF
timeFrame: at 8:30, baseline of the day shift
measure: blood samples proinflammatory cytokines
timeFrame: at 8:30, at the end of the night shift
measure: blood samples proinflammatory cytokines
timeFrame: at 8:30, baseline of the day shift
measure: blood samples telomeres lengh
timeFrame: at 8:30, at the end of the night shift
measure: blood samples telomeres lengh
timeFrame: at 8:30, baseline of the day shift
measure: Burnout
timeFrame: day 1
measure: Depression
timeFrame: day 1
measure: Anxiety
timeFrame: day 1
measure: Life satisfaction
timeFrame: day 1
measure: Lifestyle
timeFrame: day 1
measure: Life and occupational events
timeFrame: day 1
measure: Sick leave
timeFrame: day 1
measure: Clinical measurements height
timeFrame: day 1
measure: Clinical measurements weight
timeFrame: day 1
measure: diastolic blood pressure
timeFrame: at 18:30, baseline of the night shift
measure: systolic blood pressure
timeFrame: at 18:30, baseline of the night shift
measure: diastolic blood pressure
timeFrame: at 8:30, at the end of the night shift
measure: systolic blood pressure
timeFrame: at 8:30, at the end of the night shift
measure: diastolic blood pressure
timeFrame: at 8:30, baseline of the day shift
measure: systolic blood pressure
timeFrame: at 8:30, baseline of the day shift
measure: diastolic blood pressure
timeFrame: at 18:30, end of day shift
measure: systolic blood pressure
timeFrame: at 18:30, end of day shift
measure: skin conductance
timeFrame: from 18:30 to 8:30, during the 14 hours of night shift
measure: skin conductance
timeFrame: from 8:30 to 18:30, during the 10 hours of day shift
measure: Genetic factors ACE
timeFrame: at 8:30, end of the night shift
measure: Genetic factors ACE
timeFrame: at 8:30, baseline of the day shift
measure: Genetic factors (5-HTT)
timeFrame: at 8:30, end of the night shift
measure: Genetic factors (5-HTT)
timeFrame: at 8:30, baseline of the day shift
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References: