Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-27 @ 10:41 AM
Study NCT ID:
NCT06138457
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2030-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability (HRV)', 'timeFrame': '24 hours', 'description': 'Comparison of heart rate variability during one day of OSCE versus a traditional table examination.'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic', 'timeFrame': 'Once', 'description': 'Study of factors influencing heart rate variability (time of passage, anticipatory stress, sociodemographic, or lifestyle habits).'}, {'measure': 'Subjective stress', 'timeFrame': '12 hours', 'description': 'Study of stress using visual analogic scale (VAS)'}, {'measure': 'Stress correlation', 'timeFrame': 'Once', 'description': 'Study of correlation between subjective stress (VAS) and objective stress (HRV)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'exam', 'medical student', 'heart rate variability'], 'conditions': ['Heart Rate Variability', 'Stress', 'Medical Student']}, 'descriptionModule': {'briefSummary': 'We will assess stress using heart rate variability during examination on medical student. Three time of measurement will be performed. First standardized objective clinical examination, second classic table examination and third a control day.', 'detailedDescription': 'French medical students have benefited from a new evaluation method since 2020 in the form of a standardized objective clinical examination (OSCE). This examination consists of an evaluation of an initial clinical situation, in relation to a pre-identified and nationally identical objective in all Medical School. During these exams, the student has one minute of preparation then seven minutes of evaluation in front of a facilitator, member of the teaching staff. An examiner is also present in the room to search in real time for keywords intended for grading. The examiner and facilitator may or may not be tenured teachers. Students benefit from annual training organized by the Medical School of Clermont-Ferrand in which they all participate. This exam appears to be excessively stressful for students. However, there is currently no data regarding the objective measurement of the stress of these students. Heart rate variability 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...).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Medical student between fourth and sixth year of med school', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All medical student that agree to participate\n\nExclusion Criteria:\n\n* All medical student that disagree to participate'}, 'identificationModule': {'nctId': 'NCT06138457', 'acronym': 'ECOSTRESS', 'briefTitle': 'The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'The ECOSTRESS Study: Influence of the Objective Structured Clinical Examination on Stress Among Medical Student', 'orgStudyIdInfo': {'id': '2023BOUILLON-MINOIS-ECOSTRESS'}}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste Bouillon-Minois, MD, PhD', 'role': 'CONTACT', 'email': 'jbbouillon-minois@chu-clermontferrand.fr', 'phone': '+33 4 73 75 19 99'}, {'name': 'Alexandre Lautrette, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frédéric Dutheil, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical School of Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT'}, {'name': 'Jean-Baptiste BOUILLON-MINOIS', 'role': 'PRINCIPAL_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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}