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

Stress Clinical Trial

— COVISTRESS HRV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954105
• Other study ID #: 2020 COVISTRESS HRV
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: January 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Emergency health care worker

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Stress

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France, Wittyfit, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stress	Stress level will be assessed by questionnaire	hours 0 at day 1
Secondary	Stress	Stress level will be assessed by questionnaire	hours 24 at day 1
Secondary	Perception of the epidemic	Perception of the epidemic will be assessed by questionnaire	day 1
Secondary	Sociodemographic factors and lifestyle habits	Sociodemographic factors and lifestyle habits will be assessed by questionnaire	day 1