Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT07228767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Surgeons' Mental Fatigue Based on Operating Time
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': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Measurement of surgeons' mental fatigue using visual analog scales from 0 (no fatigue, perfectly clear mind) to 100 (extreme fatigue, inability to maintain concentration).", 'timeFrame': 'Before and after surgical procedures during 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Intervention']}, 'descriptionModule': {'briefSummary': "In May 2023, the French National Authority for Health published a solution for patient safety regarding tunnel vision. This concept, which is uncommon in the medical field, is defined as any situation in which a professional's attention is so focused on a goal that they do not hear or see warning signs that should prompt them to change their approach or even stop before an adverse event associated with care occurs.\n\nTo better understand the causes of medical errors, the research will assess surgeons' mental fatigue and the factors associated with it. This fatigue, which occurs after or during prolonged periods of intense cognitive activity, is associated with a temporary inability to maintain optimal cognitive performance. Assessing mental fatigue is crucial in surgeons, as it can directly affect their ability to perform complex procedures and make critical decisions. The aim of this research is to examine the factors that may influence the level of mental fatigue and cognitive load in surgeons during surgical procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgeons in the Digestive Surgery Department at CHD Vendée', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgeon working in the digestive surgery department at CHD Vendée\n* Surgeon capable of understanding the protocol and willing to participate in the research\n\nExclusion Criteria:\n\n* Surgeon unable to be available for the entire duration of the research'}, 'identificationModule': {'nctId': 'NCT07228767', 'acronym': 'COGNICHIR', 'briefTitle': "Assessment of Surgeons' Mental Fatigue Based on Operating Time", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': "Assessment of Surgeons' Mental Fatigue Based on Operating Time", 'orgStudyIdInfo': {'id': 'CHD25_0013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgeons from the Digestive Surgery Department at the Vendée Departmental Hospital Center.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'contacts': [{'name': 'Emeric ABET', 'role': 'CONTACT', 'email': 'emeric.abet@ght85.fr', 'phone': '251446572', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Départemental Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}], 'centralContacts': [{'name': 'Chloé MOREAU', 'role': 'CONTACT', 'email': 'promotion.urc@chd-vendee.fr', 'phone': '251446572', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Emeric ABET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Départemental Vendée'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}