Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT04954105
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart-Rate Variability (HRV)', 'timeFrame': 'up to day 1', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'hours 0 at day 1', 'description': 'Stress level will be assessed by questionnaire'}, {'measure': 'Stress', 'timeFrame': 'hours 24 at day 1', 'description': 'Stress level will be assessed by questionnaire'}, {'measure': 'Perception of the epidemic', 'timeFrame': 'day 1', 'description': 'Perception of the epidemic will be assessed by questionnaire'}, {'measure': 'Sociodemographic factors and lifestyle habits', 'timeFrame': 'day 1', 'description': 'Sociodemographic factors and lifestyle habits will be assessed by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'Coronavirus', 'HAZMAT', 'Epidemics'], 'conditions': ['Stress', 'Heart Rate Variability, Biomarker of Stress', 'Burnout']}, 'descriptionModule': {'briefSummary': '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.).', 'detailedDescription': '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".\n\nEach 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency health care worker', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency health care worker\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04954105', 'acronym': 'COVISTRESS HRV', 'briefTitle': 'Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers', 'orgStudyIdInfo': {'id': '2020 COVISTRESS HRV'}}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT'}, {'name': 'Jean-Baptiste Bouillon-Minois', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Frédéric Dutheil', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU clermont-ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '334.73.754.963'}], 'overallOfficials': [{'name': 'Jean-Baptiste Bouillon-Minois', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France', 'class': 'UNKNOWN'}, {'name': 'UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France', 'class': 'UNKNOWN'}, {'name': 'Wittyfit, Paris, France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}