StressCOVISTRESS HRVNCT04954105
Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
An observational study of Stress and Heart Rate Variability, Biomarker of Stress, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Heart Rate Variability, Biomarker of Stress, Burnout
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency health care worker
Who may be able to join
- Emergency health care worker
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Jean-Baptiste Bouillon-Minois
About this study
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.).
Read the 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)
- Conditions
- Stress, Heart Rate Variability, Biomarker of Stress, Burnout
- Keywords
- Stress, Coronavirus, HAZMAT, Epidemics
- Medical subject headings
- Burnout, Psychological, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 1
Secondary outcomes (4)
Stress
Stress level will be assessed by questionnaire
Measured: hours 0 at day 1
Stress
Stress level will be assessed by questionnaire
Measured: hours 24 at day 1
Perception of the epidemic
Perception of the epidemic will be assessed by questionnaire
Measured: day 1
Sociodemographic factors and lifestyle habits
Sociodemographic factors and lifestyle habits will be assessed by questionnaire
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start15 Apr 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France, Wittyfit, Paris, France
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Bouillon-Minois, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954105
- Sponsor's protocol ID
- 2020 COVISTRESS HRV
- Acronym
- COVISTRESS HRV
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
- ClinicalTrials.gov ID
- NCT04954105
- Acronym / sponsor ID
- COVISTRESS HRV / 2020 COVISTRESS HRV
- Conditions
- Stress, Heart Rate Variability, Biomarker of Stress, Burnout
- Keywords
- Stress, Coronavirus, HAZMAT, Epidemics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France, Wittyfit, Paris, France
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency health care worker
Key inclusion criteria (1 listed)
- Emergency health care worker
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Stress
Time frame: hours 0 at day 1
Stress
Time frame: hours 24 at day 1
Perception of the epidemic
Time frame: day 1
Sociodemographic factors and lifestyle habits
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Bouillon-Minois principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Heart Rate Variability, Biomarker of Stress, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-Rate Variability (HRV) (time frame: up to day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.