Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 8:23 AM
Study NCT ID:
NCT06938594
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-22
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Working With Your Body in the Operating Room. The Case of Operating Room Nurses (RCIBO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'References to emotions in interviews', 'timeFrame': 'From enrollment to the end of treatment at 1 year'}], 'secondaryOutcomes': [{'measure': 'Identification of body postures, verbal and non-verbal communication, reactions and interactions of professionals during observations in the operating rooms', 'timeFrame': 'From enrollment to the end of treatment at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['operating room nurses', 'opened bodies', 'surgery'], 'conditions': ['Nurses', 'Operating Rooms']}, 'descriptionModule': {'briefSummary': "The undocumented observation, repeatedly observed in the operating rooms, of discomfort, including fainting, among medical and paramedical novices working in contact with surgical breaches raises questions about the mechanisms put in place to cope with what seems initially unimaginable. Indeed, accounts in the social sciences show that the surgical opening of a living person is, in some ways, a transgressive act, forbidden outside the operating room. By spilling blood, it induces a 'symbolic disorder' described by Mary Douglas, that is contained through ritualized practices, predispositions towards objectification, and injunctions to control affects. The use of surgical drapes allows for the partial erasure of the person being operated on, who is no longer seen as a subject, but as an object of care - a dehumanized body or 'image-object' described by Amandine Klipfel. It is possible that ORNs are gradually adapting to negotiate the reconfiguration of bodies in the operating room, the transgression inherent in the surgical opening of a living person, and the personal resonance this may have for them. The investigator questions the specificities of their profession and their physical, emotional, and cognitive relationships following the initial shock of confronting open bodies. Is it possible to grow accustomed to or adapt to open bodies to the point of no longer experiencing difficulties related to what was once unthinkable? The investigator aims to understand what becomes of these initially unrepresentable experiences and roles ORNs have in redefining the bodies present - the processes of objectification and rehumanization of patients in the operating rooms. This doctoral study grasps the cognitive and imaginary constructions they experience in France and Canada."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Operating room nurses', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* operating room nurses\n* Student nurses and operating room nurses\n* Supervisors\n* Doctors, interns and externs\n* Surgeons\n* Midwives and midwifery students\n* Hospital cleaning staff\n* Nursing assistants\n* Biomedical staff\n\nExclusion Criteria:\n\n* People not involved in surgical operations\n* People refusing to take part in the study'}, 'identificationModule': {'nctId': 'NCT06938594', 'acronym': 'RCIBO', 'briefTitle': 'Working With Your Body in the Operating Room. The Case of Operating Room Nurses (RCIBO)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Working With Your Body in the Operating Room. The Case of Operating Room Nurses', 'orgStudyIdInfo': {'id': '29BRC24.0311 - RCIBO'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}