Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT03516058
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Comfort level', 'timeFrame': 'within 1 week after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}, {'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Comfort level', 'timeFrame': 'within 2 months after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}, {'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level', 'timeFrame': 'within 1 week after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}, {'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level', 'timeFrame': 'within 2 months after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}, {'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level', 'timeFrame': 'within 1 week after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}, {'measure': 'impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level', 'timeFrame': 'within 2 months after training session', 'description': '5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesiology Trainee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model.\n\nThe residents filled out a questionnaire before and after the training session. The questionnaires consisted of knowledge including ultrasound anatomy and block technique, comfort, confidence, and axiety levels for the TAP block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants included second-year residents, third-year residents who can participate in the anesthesiology simulation training.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03516058', 'briefTitle': 'Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model', 'orgStudyIdInfo': {'id': '4-2018-0208'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Simulation-Based Education', 'type': 'OTHER', 'description': "Participating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session.\n\nThe residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training."}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}