Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-29 @ 11:31 PM
Study NCT ID:
NCT04040556
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Student Learning by Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-class Self-directed learning time', 'timeFrame': '1 month before class', 'description': 'Time spent for studying by the student, themselves, prior the simulation class'}, {'measure': 'Post-class Self-directed learning time', 'timeFrame': 'upto 3 months after class', 'description': 'Time spent for studying by the student, themselves, after the simulation class'}], 'secondaryOutcomes': [{'measure': 'Knowledge retention', 'timeFrame': 'upto 3 months after class', 'description': 'The percentage of knowledge (in pediatric anesthesia topic) retain after class'}, {'measure': 'Level of self-confidence to treat the real patient', 'timeFrame': 'upto 3 months after class', 'description': 'Level of self-confidence to treat the real patient after class'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre and Post Simulation Session Self-directed Learning Time']}, 'descriptionModule': {'briefSummary': 'As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects.\n\nSimulation is now accepted as the way of teaching for adult learners. This learning method can help students to apply their knowledge, practical skills and non-technical skills. A systematic review study showed that self-directed learning (SDL) in health professions education is associated with moderate improvement in the knowledge domain. SDL also help the learners to improve self-efficacy and the learning outcomes in complicated tasks.In this study, the investigators wanted to evaluate that simulation can enhance student to do SDL in the both pre and post session period.', 'detailedDescription': "After approval from the instution's Ethics Committee, a prospective cohort study was conducted between November 2017 to March 2018. Twenty-five anesthesia residents were participated in this study. Students were noticed about the simulation classes which are emergencies in pediatric anesthesia and complications at one-month prior the day of practice. The list of standard references was given. On the day of study, at the institute's simulation center, students were voluntarily separated into two groups, directed- learner and observer. Post class debriefing sessions were done as routine activities. After the class, the investigator invited the students to be enrolled in this study by using the flyers. Following the consent process, three consecutive questionnaires (day 0 ,30, 90) were sent to the subjects. The data analysis will be done by using R program. The statistically significance in this study was classified at p \\<0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Anesthesia residences who are currently studying in the department of Anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesia residences who are currently studying in the department of Anesthesia\n\nExclusion Criteria:\n\n* Refuse to participate'}, 'identificationModule': {'nctId': 'NCT04040556', 'briefTitle': 'Enhancing Student Learning by Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Enhancing Student Learning by Simulation', 'orgStudyIdInfo': {'id': 'Simulation SDL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anesthesia residence', 'description': 'anesthesia residences who currently study in the department of Anesthesia and voluntarily enrolled into the study', 'interventionNames': ['Other: Simulation class']}], 'interventions': [{'name': 'Simulation class', 'type': 'OTHER', 'otherNames': ['Simulation session'], 'description': 'Pediatric anesthesia simulation class for anesthesia residences', 'armGroupLabels': ['anesthesia residence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Ngamjit Pattaravit', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'Ngamjit Pattaravit', 'investigatorAffiliation': 'Prince of Songkla University'}}}}