Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-04 @ 12:21 PM
Study NCT ID:
NCT06506851
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental Group (AR-based Training):\n\nNurses receive AR-based training with Microsoft HoloLens 2®, immersing them in interactive simulations for hands-on learning.\n\nControl Group (Traditional Self-Learning):\n\nNurses follow traditional guideline-based self-learning methods without augmented reality technology.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Educational Satisfaction Evaluation', 'timeFrame': 'Educational satisfaction will be assessed immediately after the completion of the training program.', 'description': "This evaluation assesses nurses' satisfaction with the educational program. It includes measures of confidence, relevance, and willingness to recommend the training to others using a structured questionnaire."}], 'primaryOutcomes': [{'measure': 'Clinical Competency', 'timeFrame': 'before training, immediately after training', 'description': "This measurement assesses nurses' clinical competency in rapid infusion procedures. It includes evaluation of learning time, performance time, accuracy, and assistance requests."}], 'secondaryOutcomes': [{'measure': 'Self-efficacy', 'timeFrame': 'efore training, immediately after training', 'description': "This assessment measures nurses' self-efficacy in rapid infusion procedures using a modified self-efficacy scale. It evaluates confidence levels in performing tasks related to rapid infusion."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality', 'Education, Nursing', 'Blood Transfusion', 'Self-efficacy', 'Educational Satisfaction', 'Clinical Competency', 'Critical Care'], 'conditions': ['Equipment and Supplies', 'Augmented Reality', "Nurse's Role"]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:\n\nDoes AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?\n\nParticipants will:\n\nReceive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.', 'detailedDescription': "In critical situations like hypovolemic shock, nurses must master skills for using devices like the Level-1® rapid infusion system. However, limited exposure poses challenges. Augmented reality (AR) offers a solution by providing realistic practice scenarios. While AR has shown effectiveness in cardiopulmonary resuscitation and intubation education, its application in Level-1® training remains underexplored.\n\nThis study was conducted at the Samsung Medical Center in Seoul, Korea, and involved 42 practical nurses without prior Level-1® experience. Participants were randomly assigned to one of two groups: the experimental group, which received AR-based training using Microsoft HoloLens 2®, and the control group, which followed traditional guideline-based self-learning.\n\nThe study aimed to investigate the impact of AR-based Level-1® education on nurses' clinical performance, self-efficacy, and educational satisfaction. Clinical performance, self-efficacy, and educational satisfaction were assessed through structured measurements.\n\nResults data and conclusions drawn from the data are excluded from this section and will be reported separately in the Results Section of the record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness to participate voluntarily and understanding of the study's purpose.\n* No prior experience with the Level-1® rapid infusion system.\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria.\n* Prior experience with the Level-1® rapid infusion system.\n* Inability to comprehend the study's purpose or express voluntary participation.\n* Inability to attend required training and evaluations."}, 'identificationModule': {'nctId': 'NCT06506851', 'briefTitle': 'Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': "Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®) Education on Nurse's Clinical Competency, Self-efficacy, and Educational Satisfaction: Randomised Controlled Trial", 'orgStudyIdInfo': {'id': '2023-06-084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR-based Training Group', 'description': 'Practical nurses in this arm receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization.', 'interventionNames': ['Other: AR-based Training with Microsoft HoloLens 2®']}, {'type': 'SHAM_COMPARATOR', 'label': 'Traditional Self-Learning Group', 'description': 'Practical nurses in this arm follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills.', 'interventionNames': ['Other: Traditional Guideline-based Self-Learning']}], 'interventions': [{'name': 'AR-based Training with Microsoft HoloLens 2®', 'type': 'OTHER', 'description': 'Practical nurses in this group receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization.', 'armGroupLabels': ['AR-based Training Group']}, {'name': 'Traditional Guideline-based Self-Learning', 'type': 'OTHER', 'description': 'Practical nurses in this group follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills.', 'armGroupLabels': ['Traditional Self-Learning Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'meonghi son, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}