Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT04350151
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Workload', 'timeFrame': 'baseline', 'description': 'number of work-hours per week'}, {'measure': 'Gender', 'timeFrame': 'baseline', 'description': 'Male, female'}], 'primaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'baseline', 'description': 'Investigation of the anxiety and depression with 14 questions, the cut-off score is more than 11 for anxiety or depression'}, {'measure': 'Copenhagen Burnout Inventory (CBI)', 'timeFrame': 'baseline', 'description': 'Investigation of the burnout on 3 axes: personal, professional and relational with 19 questions, the cut-off score is 50 to identify a burnout'}, {'measure': "Karacek's questionnaire", 'timeFrame': 'baseline', 'description': 'Investigation of the stress at work'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'baseline', 'description': 'Investigation of the stress with 10 questions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout, Professional', 'Intensive Care', 'Anesthesia', 'Depression, Anxiety', 'Stress, Psychological', 'Fatigue', 'Work Load']}, 'descriptionModule': {'briefSummary': 'Psychological distress is a significant problem for healthcare professionals and students in training. The investigator question the prevalence of this problem in French residents in anaesthesia and intensive care training.', 'detailedDescription': "The investigator performed an observational study on the national population of anaesthesia residents. A questionnaire was sent to all residents composed with validated questionnaires analyzing psychological distress (Hospital Anxiety and Depression Scale (HADS), Copenhagen Burnout Inventory (CBI), Perceived Stress Scale (PSS), Karasek's questionnaire; work-related questions (work hours per week, night shift per month, application of safety rest after night shift, average time to start and end work, break time and time for food per day; two semi-open work-related questions (main stressor during internship, professional orientation); a free verbatim."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'French resident of intensive care and anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resident of intensive care or anesthesia, french\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04350151', 'acronym': 'PSY-DESAR', 'briefTitle': 'National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents', 'organization': {'class': 'OTHER', 'fullName': 'Facteurs Humains en Santé'}, 'officialTitle': 'National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents', 'orgStudyIdInfo': {'id': '20200316'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'BEHAVIORAL', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75011', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Facteurs Humains en Santé', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'At the end of the survey'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Facteurs Humains en Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dominique FLETCHER MD-PhD', 'class': 'UNKNOWN'}, {'name': 'François Marty MD', 'class': 'UNKNOWN'}, {'name': 'Dinh Phong Nguyen MD', 'class': 'UNKNOWN'}, {'name': 'Loic Druette MD', 'class': 'UNKNOWN'}, {'name': 'Benoit Plaud MD-PhD', 'class': 'UNKNOWN'}, {'name': 'Clément Duret MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'François JAULIN', 'investigatorAffiliation': 'Facteurs Humains en Santé'}}}}