Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04533893
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2020-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-29', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-29', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Getting BLS(Basic Life Support Training) performance scores from serious gaming module, hands -on module with sensor data and OSCE exam on day 1.', 'timeFrame': 'One day', 'description': 'Serious gaming module, hands -on module with sensor data and OSCE exam had the same scoring criteria depending European Resuscitation Council Basic Life Support 2015 Algorithm. The scores were calculated over 100 points, whereas higher scores meant better scores. The participants were considered as successful, if at least 80 points out of 100 were obtained.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Resuscitation', 'Simulation Training']}, 'referencesModule': {'references': [{'pmid': '33237035', 'type': 'DERIVED', 'citation': 'Aksoy ME. Comparing Basic Life Support Serious Gaming Scores With Hands-on Training Platform Performance Scores: Pilot Simulation Study for Basic Life Support Training. JMIR Serious Games. 2020 Nov 25;8(4):e24166. doi: 10.2196/24166.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is creating this platform and investigating whether performance evaluation of BLS trainings would be more objective compared to conventional OSCE (Objective Structured Clinical Examination) exams, if these evaluations were carried out with the platform which is combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors.", 'detailedDescription': "The participants of this study consisted of 25 volunteers among Acibadem Mehmet Ali Aydinlar University students without prior knowledge of basic life support protocol. 11 Participants (44.0%) were male, 14 (56.0%) were female. The participants were informed about the study and signed consent forms before participating the study. After a brief introduction of the serious gaming module, the participants were asked to choose the self-test mode of the serious game module. The participants' number of attempts was not limited. Following serious game based training, the hands-on training module combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation. After familiarization with the system using self-training mode, the participants were asked to proceed the BLS Hands-on training app with the simulator under the supervision of the educator. The simulation sessions were also recorded in order to use these recordings for conventional OSCE (Objective Structured Clinical Examination) performance evaluation. Conventional OSCE score of each participant was obtained by watching the recorded sessions of BLS trainings.Spearman's rho correlation test was used for calculating the correlation between serious gaming, hands on training module with including sensor data from the simulator and OSCE scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The participants of this study consisted of 25 volunteers among Acıbadem Mehmet Ali Aydinlar University students without prior knowledge of basic life support protocol. 11 Participants (44.0%) were male, 14 (56.0%) were female. The mean age of the participants was 24,2 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having no prior Basic Life Support Training\n\nExclusion Criteria:\n\n* Having prior Basic Life Support Training'}, 'identificationModule': {'nctId': 'NCT04533893', 'briefTitle': 'Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Comparing Basic Life Support Performance Data Acquired From Serious Game Based Module and Simulation Based Hands on Training Via Built in Sensors of Simulators', 'orgStudyIdInfo': {'id': 'ATADEK-2020/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BLS Training Group (Students without prior BLS Training)', 'description': '1. After completing training mode of the serious game module, participants were asked to choose the self-test mode of the serious game module.\n2. the participants were asked to practice their hands-on skills in simulation center under the supervision of educators. After familiarization with the system using self-training mode, the participants were asked to proceed the BLS Hands-on training app with the simulator under the supervision of the educator.\n3. Conventional OSCE score of each participant was obtained by watching the recorded sessions of BLS trainings.', 'interventionNames': ['Other: Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores']}], 'interventions': [{'name': 'Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores', 'type': 'OTHER', 'otherNames': ['Basic Life Support Serious Game Module'], 'description': "Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.", 'armGroupLabels': ['BLS Training Group (Students without prior BLS Training)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Non-US/Canada', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Mehmet Ali Aydinlar University - CASE (Center of Advanced Simulation and Education)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet Emin Aksoy, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University Case(center Of Advanced Simulation And Education)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of CASE(Center of Advamnced Simulation and Education)', 'investigatorFullName': 'Emin Aksoy', 'investigatorAffiliation': 'Acibadem University'}}}}