Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers (COVISTRESS HRV)

July 7, 2021 updated by: University Hospital, Clermont-Ferrand

The COVID-19 pandemic is an exceptional and particularly anxiety-provoking health situation. In particular, for healthcare professionals who come into contact with patients who are contaminated or suspected of contamination, such as emergency rooms. The management of these patients requires reinforced protective equipment. However, in the context of this pandemic, data is currently non-existent on the objective measurement of the stress of these professionals. Sinus variability of heart rate is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc.).

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is an observational study. In the emergency room, each participant will wear a heart rate monitor and a consumer watch throughout the working day (there will be no measurement on duty at night, nor measurement at home). The days will be notified as being in the "COVID sector", "non-COVID sector" or "Trauma Room".

Each participant will complete a questionnaire comprising visual analog scales on the feeling (health concern, stress, fatigue, quality of sleep, anxiety, morale, burnout, decisional latitude, psychological demand, support, self-esteem), time of start and end of work, and socio-demographic data (sex, age, weight, height, smoking)

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clermont-Ferrand, France
    - Recruiting
    - CHU Clermont-Ferrand
    - Sub-Investigator:
      
      Frédéric DUTHEIL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Emergency health care worker

Description

Inclusion Criteria:

Emergency health care worker

Exclusion Criteria:

refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart-Rate Variability (HRV) Time Frame: up to day 1	HRV is a measure of the variation in time between each heartbeat. This variation is controlled by the autonomic nervous system. It works regardless of our desire and regulates, among other things, our heart rate, blood pressure, breathing, and digestion. It will be assess by heart rate monitor	up to day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress Time Frame: hours 0 at day 1	Stress level will be assessed by questionnaire	hours 0 at day 1
Stress Time Frame: hours 24 at day 1	Stress level will be assessed by questionnaire	hours 24 at day 1
Perception of the epidemic Time Frame: day 1	Perception of the epidemic will be assessed by questionnaire	day 1
Sociodemographic factors and lifestyle habits Time Frame: day 1	Sociodemographic factors and lifestyle habits will be assessed by questionnaire	day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France

UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France

Wittyfit, Paris, France

Investigators

Principal Investigator: Jean-Baptiste BOUILLON-MINOIS, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)