Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:35 AM
Study NCT ID:
NCT05393206
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Medical Student Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of OSCE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D000070263', 'term': 'Sleep Hygiene'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 490}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-15', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief cope scale', 'timeFrame': 'measured in the half-hour prior to the OSCEs', 'description': 'Brief Cope Scale level (from 2: minimum to 8 points : maximum) on the day of the OSCE'}], 'secondaryOutcomes': [{'measure': 'Coping and characterisation of stress', 'timeFrame': 'measured in the half-hour prior to the OSCEs', 'description': 'Correlation between coping methods according to BCS and characterisation of stress (from negative to positive, visual analogous scale) on the day of the OSCE'}, {'measure': 'Coping and self-confidence', 'timeFrame': 'measured in the half-hour prior to the OSCEs', 'description': 'Correlation between coping methods according to BCS and the level of confidence (visual scale) on the day of the OSCE'}, {'measure': 'Coping and inner resources', 'timeFrame': 'measured in the half-hour prior to the OSCEs', 'description': 'Correlation between coping methods according to BCS and the level of resourcefulness (visual scale) on the day of the OSCE (Spearman method)'}, {'measure': 'Coping and physical activity', 'timeFrame': 'measured in the half-hour prior to (BCS) and in the half-hour after (GPAQ) the OSCEs', 'description': 'Correlation between coping methods according to BCS and the level of physical activity assessed by the GPAQ questionnaire (Global Physical Activity Questionnaire) in time of physical activity (minutes)'}, {'measure': 'Coping and sleep quality', 'timeFrame': 'measured in the half-hour prior to (BCS) and in the half-hour after (Pittsburgh Sleep Quality Index (PSQI from 0 minimum to 21 maximum)) the OSCEs', 'description': 'Correlation between coping methods according to BCS and the score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory)'}, {'measure': 'Link between sleep quality and stress', 'timeFrame': 'measured in the half-hour prior to (stress level) and in the half-hour after (PSQI) the OSCEs', 'description': 'Correlation between score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory) and the level of stress (visual analogous scale) on the day of the OSCE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'coping', 'exam', 'medical students', 'sleep hygiene', 'physical activity'], 'conditions': ['Stress Reaction', 'Coping Behavior', 'Exam Stress', 'Sleep Hygiene', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '38760478', 'type': 'DERIVED', 'citation': "Barret N, Guillaumee T, Rimmele T, Cortet M, Mazza S, Duclos A, Rode G, Lilot M, Schlatter S. Associations of coping and health-related behaviors with medical students' well-being and performance during objective structured clinical examination. Sci Rep. 2024 May 17;14(1):11298. doi: 10.1038/s41598-024-61800-1."}]}, 'descriptionModule': {'briefSummary': 'Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress.\n\nThe differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress.\n\nWe will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.', 'detailedDescription': 'This observational study will be conducted between the 17th and 19th of May at the Claude Bernard University (Lyon, France), during the OSCEs of the 4th year medical students. Their signed consent will be required before inclusion to the study.\n\nBefore the test begin, they will be given a few questionnaires to fill, including the Brief Cope Scale, visual analogous scales of their level of stress, level of confidence and level of resourcefulness. Coping methods are categorized in 4 types : positive thinking, active resolution, social support and avoidance. We will also ask them about their physical activity and their quality of sleep prior the OSCEs.\n\nAfter the test, we will ask them once again their level of stress (visual analogous scale).\n\nThe main objective of this study is to demonstrate the link between the different methods of coping and the level of stress on the day of the OSCEs. Secondary objective is to have better insight and understanding over the relationship between coping methods and health-related problematics when linked to anxiety generated by exams.\n\nAll these data will be compared to a previous similar study conducted by our team of investigators on the same group of students, during their academical OSCEs in december 2021 (ECOSTRESS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fourth year medical student of the Claude Bernard University. All over eighteen years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fourth year medical student of Claude Bernard University participating to the OSCEs of May 2022\n\nExclusion Criteria:\n\n* No signed consent'}, 'identificationModule': {'nctId': 'NCT05393206', 'briefTitle': 'Influence of Medical Student Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of OSCE', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': 'Influence of Medical Students Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of the OSCEs', 'orgStudyIdInfo': {'id': 'Cope&stress'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Claude Bernard University', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Gilles Rodes, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Claude Bernard University'}, {'name': 'Marc Lilot, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Claude Bernard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Lilot Marc', 'investigatorAffiliation': 'Claude Bernard University'}}}}