Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT06358768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'teamwork', 'timeFrame': '1 month', 'description': 'Scoring the teamwork efficacy (1-10)'}, {'measure': 'skills', 'timeFrame': '1 month', 'description': 'improvement score (1-10)'}], 'secondaryOutcomes': [{'measure': 'scenario quality', 'timeFrame': '1 month', 'description': 'is the scenario adherent to reality with a score(1-5)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PPH', 'actor scenario', 'improve skills', 'improve teamwork reactions'], 'conditions': ['PPH - Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management', 'detailedDescription': "Obstetricians, midwives, anesthesiologists, surgical theatre nurses, and sanitary collaborators are enrolled voluntary in a teamwork (2 gynecologists, 2 midwives, 1 anesthesiologist, 1 surgical theatre nurse, and 1 sanitary collaborator) for managing a PPH scenario. 2 different teamworks will attend a frontal lecture of 30' and afterwards they attend a scenario with actors/facilitators (enrolled within ObGyn residents) or attend a scenario with a high-fidelity mannequin after a questionnaire indicating previous experiences and skills (at the end they accept video recording of the scenario and the use of data for scientific reasons). The teamwork is recorded and an extensive debriefing is conducted using the video records and a dataset indicating positive and negative approach. After they will answer a questionnaire indicating the use of this scenario and indicating how it is compared to reality. Personal approach to teamwork job is also described."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'persons working in our hospitals', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* personnel working in labour ward and surgical theatre\n* Volunteers\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06358768', 'acronym': 'PPH', 'briefTitle': 'Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Post-Partum Hemorrhage and Improvement in Technical Skills on Different Rules Using Actors Scenario', 'orgStudyIdInfo': {'id': 'ObGynEASC005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gynecologists', 'description': 'ObGyn specialists', 'interventionNames': ['Other: teamwork job improvement overall', 'Other: teamwork job improvement in actor scenario vs mannequin scenario']}, {'label': 'Midwives', 'description': 'Midwives registered', 'interventionNames': ['Other: teamwork job improvement overall', 'Other: teamwork job improvement in actor scenario vs mannequin scenario']}, {'label': 'Anesthesiologists', 'description': 'Anesthesiologists specialists', 'interventionNames': ['Other: teamwork job improvement overall', 'Other: teamwork job improvement in actor scenario vs mannequin scenario']}, {'label': 'Surgical theatre nurse', 'description': 'nurse', 'interventionNames': ['Other: teamwork job improvement overall', 'Other: teamwork job improvement in actor scenario vs mannequin scenario']}, {'label': 'Sanitary support personnel', 'description': 'SSP regularly working in labour ward', 'interventionNames': ['Other: teamwork job improvement overall', 'Other: teamwork job improvement in actor scenario vs mannequin scenario']}], 'interventions': [{'name': 'teamwork job improvement overall', 'type': 'OTHER', 'otherNames': ['skills improvement'], 'description': 'increase of teamwork capacities and skills improvement', 'armGroupLabels': ['Anesthesiologists', 'Gynecologists', 'Midwives', 'Sanitary support personnel', 'Surgical theatre nurse']}, {'name': 'teamwork job improvement in actor scenario vs mannequin scenario', 'type': 'OTHER', 'description': 'increase of teamwork capacities and skills improvement. Comparison within different roles and different scenario learning', 'armGroupLabels': ['Anesthesiologists', 'Gynecologists', 'Midwives', 'Sanitary support personnel', 'Surgical theatre nurse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Pescara', 'state': 'PE', 'country': 'Italy', 'contacts': [{'name': 'Claudio Celentano, MD', 'role': 'CONTACT', 'email': 'celentanoclaudio70@gmail.com', 'phone': '+393285577305'}], 'facility': 'Claudio Celentano', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Bergamo', 'country': 'Italy', 'contacts': [{'name': 'Luisa Patanè, MD', 'role': 'CONTACT', 'email': 'luisapatane@me.com', 'phone': '349 3503920\u202c', 'phoneExt': '+39'}], 'facility': 'Ospedale Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}], 'centralContacts': [{'name': 'Claudio Celentano, MD', 'role': 'CONTACT', 'email': 'celentanoclaudio70@gmail.com', 'phone': '+39 3285577305'}], 'overallOfficials': [{'name': 'Claudio Celentano, MD', 'role': 'STUDY_CHAIR', 'affiliation': "University d'annunzio"}, {'name': 'Luisa Patanè, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Giovanni XXIII Bergamo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not jet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'collaborators': [{'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Haed of unit', 'investigatorFullName': 'Claudio Celentano', 'investigatorAffiliation': "G. d'Annunzio University"}}}}