Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT07183618
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia
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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator.\n\nOn the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the stress levels before and after performing obstetric epidural anaesthesia between residents who received mental preparation and those who did not.', 'timeFrame': 'Immediately after the simulation', 'description': 'Thestress level was evaluated using the State-Trait Anxiety Inventory 6 (STAI-6) score'}], 'secondaryOutcomes': [{'measure': 'Technical performance evaluation', 'timeFrame': 'During the simulation', 'description': 'Technical performance was assessed with a validated checklist'}, {'measure': 'Non-technical skills evaluation', 'timeFrame': 'During the simulation', 'description': "Non-technical skills was measured by the Anaesthetists' Non-Technical Skills (ANTS) score"}, {'measure': 'Mental imagery abilities evaluation', 'timeFrame': 'Immediatly after the simulation', 'description': 'Mental imagery abilities was assessed via the Mental Imagery Questionnaire'}, {'measure': "Residents' satisfaction score", 'timeFrame': 'Immediatly after the simulation', 'description': 'Satisfaction score ranging from 0 to 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia residency', 'mental training', 'obstetrical epidural anesthesia', 'medical education'], 'conditions': ['Medical Education', 'Resident Education', 'Anesthesia', 'Epidural Analgesia, Obstetric']}, 'referencesModule': {'references': [{'pmid': '41248877', 'type': 'DERIVED', 'citation': 'Fluteau L, Bourdon-Castel S, Kallout J, Lefevre-Scelles A, Sibert L, Besnier E, Clavier T, Compere V, Selim J. Impact of Mental Training on the stress of anaesthesiology residents before performing obstetrical epidural analgesia: a prospective randomised educational trial. Anaesth Crit Care Pain Med. 2025 Nov 15:101675. doi: 10.1016/j.accpm.2025.101675. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Anaesthetists are trained from the beginning of their residency to perform high-risk procedures, often in high-stress environments, that can adversely affect both their technical and non-technical performance. Effective stress management is therefore essential, particularly before executing technical procedures. Recently, mental training has been introduced in the education of surgical residents to enhance performance under pressure. This study aimed to assess, using simulation, the impact of mental preparation on stress levels among anaesthesia residents before performing obstetric epidural analgesia.', 'detailedDescription': 'Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator.\n\nOn the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it. Both groups participated in a ten-minute briefing session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Eligible subjects for this study were anaesthesia and intensive care residents enrolled at the Faculty of Medicine and Pharmacy in Rouen. Residents were eligible if they were in the early stages of training (second and third years of residency) and had previously performed lumbar epidural anaesthesia multiple times in a maternity setting.\n\nExclusion Criteria: Exclusion criteria included first-year residents, as not all had performed obstetric lumbar epidural anaesthesia at the time of the study, and senior residents (fourth and fifth years).'}, 'identificationModule': {'nctId': 'NCT07183618', 'briefTitle': 'Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia: a Prospective Randomized Educational Trial', 'orgStudyIdInfo': {'id': 'E2024-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group (no mental training)', 'description': 'Residents in the control group did not undergo any mental training prior to performing epidural placement.'}, {'type': 'EXPERIMENTAL', 'label': 'Mental training group', 'description': 'Mental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure', 'interventionNames': ['Procedure: Mental training group']}], 'interventions': [{'name': 'Mental training group', 'type': 'PROCEDURE', 'description': 'Mental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure', 'armGroupLabels': ['Mental training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'state': 'Normandy', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'jean.selim', 'investigatorAffiliation': 'University Hospital, Rouen'}}}}