Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT06968260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress and Learning in Educator- vs. Software-Guided VR Training for Basic Life Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrodermal Activity', 'timeFrame': 'Up to 4 weeks', 'description': 'Electrodermal activity will be used to operationalize stress levels via Shimmer3 GSR+ (Galvanic Skin Response) Unit.'}, {'measure': 'Presence Levels', 'timeFrame': 'Up to 4 weeks', 'description': 'Presence will be measured using Presence Questionnaire. The questionnaire is 7- point likert type, with higher scores meaning increased presence. The minimum possible score is 1 and the maximum is 7.'}, {'measure': 'Instructional Skills Questionnaire', 'timeFrame': 'Up to 4 weeks', 'description': 'This questionnaire will be used to assess instructor evaluations. Items are rated on a 7-point Likert scale. Higher scores indicate better satisfaction with the course.'}, {'measure': 'Exam Scores', 'timeFrame': 'Up to 4 weeks', 'description': 'Scores on the exam module will be compared across groups. Scores will range from 1 to 100. Higher scores will indicate higher success.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Machine Guidance', 'Instructor Guidance']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will explore how instructor type-human vs. machine-affects performance, immersion, and stress during VR-based Basic Life Support (BLS) training. Participants will receive VR based education wither with a machine instructor or a human instructor and complete a simulated emergency exam. Outcomes will include procedural accuracy, physiological stress (measured via electrodermal activity), and subjective evaluations of presence and instructor effectiveness.', 'detailedDescription': "In high-stakes medical emergencies, both technical proficiency and psychological resilience are critical. Traditional Basic Life Support (BLS) training methods-such as lectures, role-play, and manikin-based practice-help students build core skills but often fall short in replicating the stress and complexity of real-world crises. As medical education evolves, virtual reality (VR) is emerging as a promising tool, offering immersive, controlled environments that simulate emergency conditions while supporting both skill acquisition and psychological engagement. However, while VR's benefits for technical training are well-established, its impact on stress management and mental preparedness remains underexplored.\n\nThis study will examine how the type of instructor-human or machine-within a VR-based training environment influences students' performance, immersion, and stress responses during BLS training. Participants will undergo VR-based BLS instruction led by either a human educator or a software-based guide, followed by a simulated emergency exam. Outcomes will be assessed through procedural accuracy, physiological stress measured via electrodermal activity (EDA), and subjective evaluations of presence and instructor effectiveness.\n\nThe findings are expected to shed light on how different instructional approaches in VR affect not only learning outcomes but also students' capacity to manage stress in high-pressure situations. By identifying how instructor type influences both competence and psychological resilience, this research aims to optimize VR-based medical training for the demands of real-world clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being older than 18\n\nExclusion Criteria:\n\n* prior completion of Basic Life Support (BLS) training\n* history of virtual reality (VR)-induced motion sickness\n* medical conditions such as vertigo or the use of medications known to cause vertigo-like symptoms'}, 'identificationModule': {'nctId': 'NCT06968260', 'briefTitle': 'Stress and Learning in Educator- vs. Software-Guided VR Training for Basic Life Support', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Comparing Physiological Stress and Learning Outcomes in Instructor- vs. Software-Guided VR Basic Life Support Training', 'orgStudyIdInfo': {'id': '2024-17/647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Machine Guidance', 'description': 'The participants will receive a machine guided education', 'interventionNames': ['Other: Education Type']}, {'type': 'EXPERIMENTAL', 'label': 'Instructor Guidance', 'description': 'Participants will receive human guided education', 'interventionNames': ['Other: Education Type']}], 'interventions': [{'name': 'Education Type', 'type': 'OTHER', 'description': 'Machine Guidance group will receive education from a software, while the Instructor Guidance Group will receive education from a human instructor.', 'armGroupLabels': ['Instructor Guidance', 'Machine Guidance']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}