Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events (JOBSTRESS)
Primary Purpose
Heart Rate Variability
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparison of biomarkers of stress
Sponsored by
About this trial
This is an interventional screening trial for Heart Rate Variability focused on measuring Heart rate variability, stress, cortisol
Eligibility Criteria
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
Sites / Locations
- Chu Clermont FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Emergency physicians
medical externship student
Arm Description
actors during the work
spectator during the emergency physician work
Outcomes
Primary Outcome Measures
heart rate variability at night work
measure of abrupt changes in HRV signals during 14 hours
heart rate variability at day work
measure of abrupt changes in HRV signals during 10 hours
Secondary Outcome Measures
Stress
measure of stress using VAS
Fatigue
measure of Fatigue using VAS
Stress
measure of stress using VAS
Fatigue
measure of Fatigue using VAS
Stress
measure of stress using VAS
Fatigue
measure of Fatigue using VAS
Fatigue
measure of Fatigue using VAS
Stress
measure of stress using VAS
Stress
measure of stress using VAS
Fatigue
measure of Fatigue using VAS
Stress
measure of stress using VAS
Fatigue
measure of Fatigue using VAS
Saliva biomarkers cortisol
measure of Cortisol
Saliva biomarkers cortisol
measure of Cortisol
Saliva biomarkers cortisol
measure of Cortisol
Saliva biomarkers cortisol
measure of Cortisol
Saliva biomarkers DHEAS
measure of DHEAS
Saliva biomarkers DHEAS
measure of DHEAS
Saliva biomarkers DHEAS
measure of DHEAS
Saliva biomarkers DHEAS
measure of DHEAS
Saliva biomarkers lgAs
measure of lgAs
Saliva biomarkers lgAs
measure of lgAs
Saliva biomarkers lgAs
measure of lgAs
Saliva biomarkers lgAs
measure of lgAs
blood samples full blood count
measure of full blood count
blood samples full blood count
measure of full blood count
blood samples HbA1c,
measure of HbA1c
blood samples HbA1c,
measure of HbA1c
blood samples HDLc and LDL-cholesterol
measure of HDLc and LDL-cholesterol
blood samples HDLc and LDL-cholesterol
measure of HDLc and LDL-cholesterol
blood samples TG
measure of TG
blood samples TG
measure of TG
blood samples Cortisol
measure of Cortisol
blood samples Cortisol
measure of Cortisol
blood samples DHEAS
measure of DHEAS
blood samples DHEAS
measure of DHEAS
blood samples vitamine D
measure of vitamine D
blood samples vitamine D
measure of vitamine D
blood samples BDNF
measure of BDNF
blood samples BDNF
measure of BDNF
blood samples proinflammatory cytokines
measure of proinflammatory cytokines
blood samples proinflammatory cytokines
measure of proinflammatory cytokines
blood samples telomeres lengh
measure of telomeres lengh
blood samples telomeres lengh
measure of telomeres lengh
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".
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".
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".
Life satisfaction
quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)
Lifestyle
Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).
Life and occupational events
Assessing factors regarding death of patients or death of a loved one by questionnaire.
Sick leave
assessing sick leave by the number of absence days the previous 6 months using a questionnaire
Clinical measurements height
measure of height
Clinical measurements weight
measure of weight
diastolic blood pressure
measure of diastolic blood pressure
systolic blood pressure
measure of systolic blood pressure
diastolic blood pressure
measure of diastolic blood pressure
systolic blood pressure
measure of systolic blood pressure
diastolic blood pressure
measure of disatolic blood pressure
systolic blood pressure
measure of systolic blood pressure
diastolic blood pressure
measure of disatolic blood pressure
systolic blood pressure
measure of systolic blood pressure
skin conductance
measure of the skin conductance
skin conductance
measure of the skin conductance
Genetic factors ACE
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Genetic factors ACE
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Genetic factors (5-HTT)
measure of the polymorphism of the serotonin transporter (5-HTT)
Genetic factors (5-HTT)
measure of the polymorphism of the serotonin transporter (5-HTT)
Full Information
NCT ID
NCT04334083
First Posted
March 25, 2020
Last Updated
April 11, 2023
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04334083
Brief Title
Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Acronym
JOBSTRESS
Official Title
Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Rate Variability
Keywords
Heart rate variability, stress, cortisol
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emergency physicians
Arm Type
Experimental
Arm Description
actors during the work
Arm Title
medical externship student
Arm Type
Experimental
Arm Description
spectator during the emergency physician work
Intervention Type
Behavioral
Intervention Name(s)
Comparison of biomarkers of stress
Intervention Description
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.
Primary Outcome Measure Information:
Title
heart rate variability at night work
Description
measure of abrupt changes in HRV signals during 14 hours
Time Frame
from 18:30 to 8:30, during the 14 hours of the night shift
Title
heart rate variability at day work
Description
measure of abrupt changes in HRV signals during 10 hours
Time Frame
from 8:30 to 18:30, during the 10 hours of the day shift
Secondary Outcome Measure Information:
Title
Stress
Description
measure of stress using VAS
Time Frame
18:30, baseline of the night shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 18:30, baseline of the night shift
Title
Stress
Description
measure of stress using VAS
Time Frame
at 8h30, at the end of the night shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 8:30, at the end of the night shift
Title
Stress
Description
measure of stress using VAS
Time Frame
at 8:30, 24 hours after the end of night shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 8:30, 24 hours after the end of night shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 18:30, 24 hours after the end of day shift
Title
Stress
Description
measure of stress using VAS
Time Frame
at 18:30, 24 hours after the end of day shift
Title
Stress
Description
measure of stress using VAS
Time Frame
at 8:30, baseline of the day shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 8:30, baseline of the day shift
Title
Stress
Description
measure of stress using VAS
Time Frame
at 18:30, end of the day shift
Title
Fatigue
Description
measure of Fatigue using VAS
Time Frame
at 18:30, end of the day shift
Title
Saliva biomarkers cortisol
Description
measure of Cortisol
Time Frame
at 18:30, baseline of the night shift
Title
Saliva biomarkers cortisol
Description
measure of Cortisol
Time Frame
at 8:30, at the end of the night shift
Title
Saliva biomarkers cortisol
Description
measure of Cortisol
Time Frame
at 8:30, baseline of the day shift
Title
Saliva biomarkers cortisol
Description
measure of Cortisol
Time Frame
at 18:30, end of the day shift
Title
Saliva biomarkers DHEAS
Description
measure of DHEAS
Time Frame
at 18:30, baseline of the night shift
Title
Saliva biomarkers DHEAS
Description
measure of DHEAS
Time Frame
at 8:30, at the end of the night shift
Title
Saliva biomarkers DHEAS
Description
measure of DHEAS
Time Frame
at 8:30, baseline of the day shift
Title
Saliva biomarkers DHEAS
Description
measure of DHEAS
Time Frame
at 18:30, end of the day shift
Title
Saliva biomarkers lgAs
Description
measure of lgAs
Time Frame
at 18:30, baseline of the night shift
Title
Saliva biomarkers lgAs
Description
measure of lgAs
Time Frame
at 8:30, at the end of the night shift
Title
Saliva biomarkers lgAs
Description
measure of lgAs
Time Frame
at 8:30, baseline of the day shift
Title
Saliva biomarkers lgAs
Description
measure of lgAs
Time Frame
at 18:30, end of the day shift
Title
blood samples full blood count
Description
measure of full blood count
Time Frame
at 8:30, at the end of the night shift
Title
blood samples full blood count
Description
measure of full blood count
Time Frame
at 8:30, baseline of the day shift
Title
blood samples HbA1c,
Description
measure of HbA1c
Time Frame
at 8:30, at the end of the night shift
Title
blood samples HbA1c,
Description
measure of HbA1c
Time Frame
at 8:30, baseline of the day shift
Title
blood samples HDLc and LDL-cholesterol
Description
measure of HDLc and LDL-cholesterol
Time Frame
at 8:30, at the end of the night shift
Title
blood samples HDLc and LDL-cholesterol
Description
measure of HDLc and LDL-cholesterol
Time Frame
at 8:30, baseline of the day shift
Title
blood samples TG
Description
measure of TG
Time Frame
at 8:30, at the end of the night shift
Title
blood samples TG
Description
measure of TG
Time Frame
at 8:30, baseline of the day shift
Title
blood samples Cortisol
Description
measure of Cortisol
Time Frame
at 8:30, at the end of the night shift
Title
blood samples Cortisol
Description
measure of Cortisol
Time Frame
at 8:30, baseline of the day shift
Title
blood samples DHEAS
Description
measure of DHEAS
Time Frame
at 8:30, at the end of the night shift
Title
blood samples DHEAS
Description
measure of DHEAS
Time Frame
at 8:30, baseline of the day shift
Title
blood samples vitamine D
Description
measure of vitamine D
Time Frame
at 8:30, at the end of the night shift
Title
blood samples vitamine D
Description
measure of vitamine D
Time Frame
at 8:30, baseline of the day shift
Title
blood samples BDNF
Description
measure of BDNF
Time Frame
at 8:30, at the end of the night shift
Title
blood samples BDNF
Description
measure of BDNF
Time Frame
at 8:30, baseline of the day shift
Title
blood samples proinflammatory cytokines
Description
measure of proinflammatory cytokines
Time Frame
at 8:30, at the end of the night shift
Title
blood samples proinflammatory cytokines
Description
measure of proinflammatory cytokines
Time Frame
at 8:30, baseline of the day shift
Title
blood samples telomeres lengh
Description
measure of telomeres lengh
Time Frame
at 8:30, at the end of the night shift
Title
blood samples telomeres lengh
Description
measure of telomeres lengh
Time Frame
at 8:30, baseline of the day shift
Title
Burnout
Description
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".
Time Frame
day 1
Title
Depression
Description
depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".
Time Frame
day 1
Title
Anxiety
Description
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".
Time Frame
day 1
Title
Life satisfaction
Description
quality of life is assessed by a brief multidimensional life satisfaction scale (BMLSS)
Time Frame
day 1
Title
Lifestyle
Description
Assessing factors regarding lifestyle are related to smoking, alcohol, coffee, food intake (questionnaires), and physical activity (Recent Physical Activity Questionnaire).
Time Frame
day 1
Title
Life and occupational events
Description
Assessing factors regarding death of patients or death of a loved one by questionnaire.
Time Frame
day 1
Title
Sick leave
Description
assessing sick leave by the number of absence days the previous 6 months using a questionnaire
Time Frame
day 1
Title
Clinical measurements height
Description
measure of height
Time Frame
day 1
Title
Clinical measurements weight
Description
measure of weight
Time Frame
day 1
Title
diastolic blood pressure
Description
measure of diastolic blood pressure
Time Frame
at 18:30, baseline of the night shift
Title
systolic blood pressure
Description
measure of systolic blood pressure
Time Frame
at 18:30, baseline of the night shift
Title
diastolic blood pressure
Description
measure of diastolic blood pressure
Time Frame
at 8:30, at the end of the night shift
Title
systolic blood pressure
Description
measure of systolic blood pressure
Time Frame
at 8:30, at the end of the night shift
Title
diastolic blood pressure
Description
measure of disatolic blood pressure
Time Frame
at 8:30, baseline of the day shift
Title
systolic blood pressure
Description
measure of systolic blood pressure
Time Frame
at 8:30, baseline of the day shift
Title
diastolic blood pressure
Description
measure of disatolic blood pressure
Time Frame
at 18:30, end of day shift
Title
systolic blood pressure
Description
measure of systolic blood pressure
Time Frame
at 18:30, end of day shift
Title
skin conductance
Description
measure of the skin conductance
Time Frame
from 18:30 to 8:30, during the 14 hours of night shift
Title
skin conductance
Description
measure of the skin conductance
Time Frame
from 8:30 to 18:30, during the 10 hours of day shift
Title
Genetic factors ACE
Description
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Time Frame
at 8:30, end of the night shift
Title
Genetic factors ACE
Description
measure of the polymorphism of angiotensin converting enzyme inhibitors (ACE
Time Frame
at 8:30, baseline of the day shift
Title
Genetic factors (5-HTT)
Description
measure of the polymorphism of the serotonin transporter (5-HTT)
Time Frame
at 8:30, end of the night shift
Title
Genetic factors (5-HTT)
Description
measure of the polymorphism of the serotonin transporter (5-HTT)
Time Frame
at 8:30, baseline of the day shift
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Dutheil
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Frédéric Dutheil
12. IPD Sharing Statement
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Biomarkes Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events
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