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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT04954105
Collaborator
University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France (Other), UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France (Other), Wittyfit, Paris, France (Other)
200
1
20.6
9.7

Study Details

Study Description

Brief Summary

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.).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
    Actual Study Start Date :
    Apr 15, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Heart-Rate Variability (HRV) [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

    Secondary Outcome Measures

    1. Stress [hours 0 at day 1]

      Stress level will be assessed by questionnaire

    2. Stress [hours 24 at day 1]

      Stress level will be assessed by questionnaire

    3. Perception of the epidemic [day 1]

      Perception of the epidemic will be assessed by questionnaire

    4. Sociodemographic factors and lifestyle habits [day 1]

      Sociodemographic factors and lifestyle habits will be assessed by questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Emergency health care worker
    Exclusion Criteria:
    • refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU clermont-ferrand Clermont-Ferrand France

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT04954105
    Other Study ID Numbers:
    • 2020 COVISTRESS HRV
    First Posted:
    Jul 8, 2021
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2021