Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05389020
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2022-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunisation Simulation Using the Real-size Infant Manikin in Medical Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge pre- and post-test questionnaire', 'timeFrame': 'Seven weeks after the immunization course', 'description': "The improvement of students' knowledge by using the real-size infant's arm and leg manikins"}, {'measure': 'Practical skill score using rubric', 'timeFrame': 'Seven weeks after the immunization course', 'description': "The improvement of students' practical skill by using the real-size infant's arm and leg manikins"}, {'measure': 'Number of students who were confident by self assessment using Likert scale questionnaire', 'timeFrame': 'Seven weeks after the immunization course', 'description': 'The confidence in doing the immunization practice after the workshop'}, {'measure': "Students' feedback questionnaire", 'timeFrame': 'Seven weeks after the immunization course', 'description': "Students' response and feedback regarding the practice using the real-size infant's arm and leg manikins"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Simulation', 'Manikin', 'Immunization', 'Vaccination'], 'conditions': ['Immunization Skills']}, 'descriptionModule': {'briefSummary': "This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the confidence in immunization after the simulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta\n* Medical students who attended immunisation workshops\n\nExclusion Criteria:\n\n* Students who refused to participate\n* Students who did not attend the immunisation workshops'}, 'identificationModule': {'nctId': 'NCT05389020', 'briefTitle': 'Immunisation Simulation Using the Real-size Infant Manikin in Medical Education', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Immunisation Simulation Using the Real-size Infant Manikin in Medical Education', 'orgStudyIdInfo': {'id': '653/UN2.F1/ETIK/PPM.00.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "70 minutes course using newly developed real-size infant's arm and leg manikin", 'interventionNames': ["Other: Newly developed real-size infant's arm and leg manikin"]}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '70 minutes course using conventional manikin'}], 'interventions': [{'name': "Newly developed real-size infant's arm and leg manikin", 'type': 'OTHER', 'description': "The control group used conventional manikins made by Nasco; meanwhile, two newly designed real-size manikins were prepared for the intervention group: the right arm and right leg. Real-size manikins were developed based on the mean of anthropometric measurement of 50 Indonesian infants' arms and legs of healthy term neonates born in Dr Cipto Mangunkusumo Hospital. The manikins were made of Thermoplastic Polyurethane (TPU) filament using three-dimensional (3D) printing technology. The manufacturing process was carried out by the Medical Physics Department, Universitas Indonesia.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'country': 'Indonesia', 'facility': 'Dr. Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Hartono Gunardi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Prof. Hartono Gunardi, MD, PhD', 'investigatorAffiliation': 'Indonesia University'}}}}