Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:58 PM
Study NCT ID:
NCT04944394
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4522}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score assessed by Global Health Questionnaire GHQ-12', 'timeFrame': 'at baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Stress']}, 'referencesModule': {'references': [{'pmid': '39927681', 'type': 'DERIVED', 'citation': 'Fournier A, Deltour V, Lheureux F, Poujol AL, Ecarnot F, Binquet C, Quenot JP, Laurent A. Association between burnout and PTSD, and perceived stress in the workplace among healthcare workers in the intensive care unit: a PsyCOVID-ICU substudy. Psychol Health Med. 2025 Apr;30(4):752-769. doi: 10.1080/13548506.2025.2454038. Epub 2025 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'SARS-COV-2 has created an unprecedented health crisis, resulting in unprecedented mobilization of all hospital professionals. The massive influx of patients overwhelmed the human, therapeutic and material resources available, and teams were confronted with an unusually heavy workload in a highly stressful emergency context. These professionals were thus exposed to a risk of over-investment in a context of acute and repetitive stress over an indefinite period of time, combining a heavy workload, emotional challenges and specific ethical issues. These factors simultaneously affected the professional sphere but also the personal and family spheres (lockdown, risk of contamination). In this context, the mental health of hospital staff is considered to be more important than ever, as emphasized on numerous occasions by the Director General of Health and the French Minister for Health and Solidarity. Mental health involves the way in which individuals respond specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the question of the mental health of hospital professionals cannot be considered without taking into account the strategies implmented to combat stress, and the factors that contribute or not to the construction and stabilization of the work environment (collaboration, support).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all professionals working in hospitals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll professionals working in hospitals Professionals involved in the organization of psychological and ethical support may also be interviewed to provide the information necessary to describe and evaluate the support provided and how it changed over time.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04944394', 'acronym': 'PsyCOVID All P', 'briefTitle': 'Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals', 'orgStudyIdInfo': {'id': 'QUENOT 2020-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hospital professionals', 'description': 'all professionals working in hospitals in France', 'interventionNames': ['Other: online questionnaire', 'Other: questionnaire survey']}], 'interventions': [{'name': 'online questionnaire', 'type': 'OTHER', 'description': 'Administration of an online questionnaire (Limesurvey platform) at M0\n\n\\- This questionnaire includes a characterization of the professional (center, profession, usual department and department during the health crisis, family situation). Generic stress factors, the traumatic impact of the crisis and collective and individual coping strategies are also collected.', 'armGroupLabels': ['hospital professionals']}, {'name': 'questionnaire survey', 'type': 'OTHER', 'description': 'A questionnaire survey of the chief physician of the intensive care unit of each hospital will make it possible to characterize the support provided by the institution and how it changed over time', 'armGroupLabels': ['hospital professionals']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}