NCT04954105

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.).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

July 6, 2021

Last Update Submit

July 7, 2021

Conditions

StressHeart Rate Variability, Biomarker of StressBurnout

Keywords

StressCoronavirusHAZMATEpidemics

Outcome Measures

Primary Outcomes (1)

  • Heart-Rate Variability (HRV)

    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 Outcomes (4)

  • Stress

    hours 0 at day 1

  • Stress

    hours 24 at day 1

  • Perception of the epidemic

    day 1

  • Sociodemographic factors and lifestyle habits

    day 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency health care worker

You may qualify if:

  • Emergency health care worker

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Burnout, PsychologicalCoronavirus Infections

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Jean-Baptiste Bouillon-Minois

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 8, 2021

Study Start

April 15, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 8, 2021

Record last verified: 2021-07

Locations

FR(1)