Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT06466993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Evaluators of performance are blind to randomisation such as outcome assessor'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlle monocentric'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-10', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PERFORMANCE', 'timeFrame': 'obtained seven days after the objectif structured clinical examination', 'description': 'Score at the objectif structured clinical examination exam from 0 minimum to 200 points maximum'}], 'secondaryOutcomes': [{'measure': 'Mean Difference of Inner Resource', 'timeFrame': 'Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)', 'description': 'Numerical Visual analog score on inner resource available perceived (from 0 to 100 : maximum)'}, {'measure': 'Mean difference of perceived impact of the intervention on performance', 'timeFrame': 'Just five minutes after the objectif structured clinical examination', 'description': 'Numerical Visual analog scales on perceived impact of the intervention on performance (from zero: negative to 100: positive)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Performance Anxiety', 'Stress', 'Coping Skills']}, 'descriptionModule': {'briefSummary': 'SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.\n\nThe aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.', 'detailedDescription': 'Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.\n\nStress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing as a coping interventions occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all volontary medical students of the second cycle that came for their exam during the sessions of June 2024 from the University of Lyon (Medecine ESt)\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06466993', 'acronym': 'ZENECOS', 'briefTitle': 'Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': 'Influence on Performance of Relaxing Breathing During Rotation Pause Before Each Station of an Objective Structured Clinical Examination for Fifth Year Medical Students', 'orgStudyIdInfo': {'id': 'ZENECOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Relaxing breathing occuring during rotation of OSCE station', 'interventionNames': ['Behavioral: Intervention of standardized relaxing breathing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Free time during rotation of OSCE station', 'interventionNames': ['Behavioral: Intervention of standardized relaxing breathing']}], 'interventions': [{'name': 'Intervention of standardized relaxing breathing', 'type': 'BEHAVIORAL', 'description': 'Relaxing breathing standardized to 6 respiratory cycles per minute that occur during rotation time before next station of OSCE start', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marc Lilot, MD PhD', 'role': 'CONTACT', 'email': 'marc.lilot@chu-lyon.fr', 'phone': '0651806521'}, {'name': 'Sophie Schlatter, PhD', 'role': 'CONTACT', 'email': 'sophie.schlatter@univ-lyon1.fr', 'phone': '0651806521'}], 'overallOfficials': [{'name': 'Gilles Rode, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lyon Est Medical Center Lyon 1 University'}, {'name': 'Evan Gouy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lyon Est Medical Center Lyon 1 University'}, {'name': 'Marion Cortet, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lyon Est Medical Center Lyon 1 University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lilot Marc', 'investigatorAffiliation': 'Claude Bernard University'}}}}