Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:33 PM
Study NCT ID:
NCT07361835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Using Virtual Reality Glasses in Prehospital Intervention Training for Crush Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}, {'id': 'D000071576', 'term': 'Crush Injuries'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prehospital crush syndrome knowledge level', 'timeFrame': 'Baseline (pre-test) and immediately after the training session (post-test).', 'description': "The knowledge level of participants is measured using the full 'prehospital crush syndrome knowledge level scale'. The scale consists of 32 items covering four sub-dimensions: general knowledge (12 items), treatment (9 items), transport (6 items), and advanced knowledge (5 items). Each correct answer is scored as 1 point, while incorrect or 'no idea' answers are scored as 0. The total score ranges from a minimum of 0 to a maximum of 32. A higher total score indicates a better understanding and a higher knowledge level of prehospital crush syndrome management."}], 'secondaryOutcomes': [{'measure': 'Educational satisfaction level', 'timeFrame': 'Immediately after completion of the training intervention.', 'description': "Participant satisfaction with the educational method (virtual reality or theoretical lecture) is measured using the 'education method satisfaction form'. This is a single-item numeric rating scale ranging from a minimum of 0 to a maximum of 10. A score of '0' indicates that the participant is not at all satisfied with the teaching method, while higher scores indicate increasing levels of satisfaction, with a score of '10' representing full satisfaction. Higher scores mean a better outcome."}, {'measure': 'Sense of presence in virtual environment', 'timeFrame': 'Immediately after completion of the virtual reality training session', 'description': "The sense of presence in the virtual reality environment is measured using the 'presence questionnaire'. This scale assesses various dimensions such as involvement, sensory fidelity, and adaptation. Each item is scored on a 5-point likert scale, ranging from a minimum of 1 to a maximum of 5. For instance, a score of '1' indicates no presence or very poor quality, while a score of '5' indicates a high level of presence or complete naturalness. A higher total score indicates a greater sense of presence and a more immersive virtual reality experience."}, {'measure': 'Technology usage level', 'timeFrame': 'Baseline (pre-test)', 'description': "Participants' orientation and interest towards technology are measured using the 'technology usage scale'. This scale consists of 13 items scored on a 5-point likert scale (1 = strongly disagree to 5 = strongly agree). The total score ranges from a minimum of 13 to a maximum of 65. A higher total score indicates a higher level of technology integration, interest, and adaptation to technological innovations in daily life."}, {'measure': 'Attitude toward virtual reality in education', 'timeFrame': 'Immediately after completion of the training session', 'description': "Participants' attitudes toward using virtual reality for learning and professional development are measured using the 'virtual reality attitude scale'. The scale consists of 9 items scored on a 5-point likert scale (1 = strongly disagree to 5 = strongly agree). The total score ranges from a minimum of 9 to a maximum of 45. A higher total score indicates a more positive attitude and higher perceived usefulness regarding the integration of virtual reality into educational processes"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehospital Care', 'Paramedics', 'Simulation Training', 'Virtual Reality Simulation'], 'conditions': ['Rhabdomyolysis', 'Virtual Reality', 'Emergency Medical Services', 'Disaster Medicine', 'Crush Injuries']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'English: Gunduz, F., & Ersoy, G. (2022). Knowledge levels of 112 ambulance service employees regarding field treatment of crush syndrome: Izmir province example. Journal of Prehospital, 7(1), 37-50.'}, {'type': 'BACKGROUND', 'citation': "English: Panus, U. (2023). Development of an education program to increase the level of knowledge about crush syndrome in paramedic students. Unpublished Master's Thesis, Ege University."}, {'pmid': '37653520', 'type': 'BACKGROUND', 'citation': 'Usuda D, Shimozawa S, Takami H, Kako Y, Sakamoto T, Shimazaki J, Inoue J, Nakayama S, Koido Y, Oba J. Crush syndrome: a review for prehospital providers and emergency clinicians. J Transl Med. 2023 Aug 31;21(1):584. doi: 10.1186/s12967-023-04416-9.'}], 'seeAlsoLinks': [{'url': 'https://www.nlm.nih.gov/mesh/', 'label': 'Medical Subject Headings (MeSH) Home Page.'}, {'url': 'https://www.bbc.com/turkce/live/64533110?page=16', 'label': 'Reports on Crush Syndrome cases after the 2023 Kahramanmaraş Earthquakes.'}]}, 'descriptionModule': {'briefSummary': 'This research is a randomized controlled study designed to develop and evaluate the effectiveness of a video-based virtual reality (VR) simulation for prehospital intervention training of crush syndrome for paramedic students. The study aims to examine the impact of VR simulation on knowledge levels, satisfaction, and sense of presence among second-year first and emergency aid students at Muğla Sıtkı Koçman University.', 'detailedDescription': 'The study will be conducted with second-year students enrolled in the first and emergency aid program at Muğla Sıtkı Koçman University, Fethiye Health Services Vocational School. Participants will be assigned to experimental and control groups using simple randomization. The experimental group will receive training via virtual reality (VR) simulation, while the control group will receive traditional theoretical education. Knowledge levels, technology use, satisfaction, and sense of presence will be measured using various validated scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBeing a second-year student currently enrolled in the first and emergency aid program at Muğla Sıtkı Koçman University.\n\nVoluntarily providing written informed consent to participate in the study. Having basic technological literacy to use virtual reality equipment.\n\nExclusion Criteria:\n\nFirst-year students who have not yet reached the relevant stage of the curriculum.\n\nStudents who have previously participated in a similar virtual reality-based crush syndrome simulation.\n\nStudents with medical conditions that may be aggravated by VR use (e.g., severe motion sickness, history of seizures).\n\nRefusal to participate voluntarily.'}, 'identificationModule': {'nctId': 'NCT07361835', 'briefTitle': 'Evaluation of the Effectiveness of Using Virtual Reality Glasses in Prehospital Intervention Training for Crush Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Evaluation of the Effectiveness of Using Virtual Reality Glasses in Prehospital Intervention Training for Crush Syndrome', 'orgStudyIdInfo': {'id': '25-11.1T/50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality-based crush syndrome training', 'description': 'Participants receive scenario-based three-dimensional virtual reality simulation training for prehospital crush syndrome management using a head-mounted display.', 'interventionNames': ['Device: Virtual reality-based crush syndrome training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional classroom-based theoretical lecture', 'description': 'Participants receive traditional classroom-based theoretical education for prehospital crush syndrome management.', 'interventionNames': ['Other: Traditional theoretical lecture']}], 'interventions': [{'name': 'Virtual reality-based crush syndrome training', 'type': 'DEVICE', 'description': 'A scenario-based three-dimensional virtual reality training program focusing on prehospital crush syndrome assessment and management.', 'armGroupLabels': ['Virtual reality-based crush syndrome training']}, {'name': 'Traditional theoretical lecture', 'type': 'OTHER', 'description': 'Conventional theoretical classroom instruction on prehospital crush syndrome assessment and management.', 'armGroupLabels': ['Traditional classroom-based theoretical lecture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48300', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Süreyya GÜMÜŞSOY, Assoc. Prof.', 'role': 'CONTACT', 'email': 'sureyya.gumussoy@ege.edu.tr', 'phone': '+90 232 311 20 58'}, {'name': 'Ali AKGÜN, PhD(c)', 'role': 'CONTACT', 'email': 'aliakgun1980@gmail.com', 'phone': '+90 252 211 59 03'}], 'facility': 'Muğla Sıtkı Koçman University, Fethiye Health Services Vocational School', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'centralContacts': [{'name': 'Süreyya GÜMÜŞSOY, Assoc. Prof.', 'role': 'CONTACT', 'email': 'sureyya.gumussoy@ege.edu.tr', 'phone': '+90 232 311 20 58'}, {'name': 'Ali AKGÜN, PhD(c)', 'role': 'CONTACT', 'email': 'aliakgun1980@gmail.com', 'phone': '+90 252 211 59 03'}], 'overallOfficials': [{'name': 'Süreyya GÜMÜŞSOY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}, {'name': 'Süreyya GÜMÜŞSOY, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mu.edu.tr/tr/personel/aliakgun', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available starting 6 months after publication and will remain accessible for up to 3 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data underlying the results reported in this study (text, tables, figures, and appendices) will be made available to researchers who provide a methodologically sound proposal. The data will be shared to achieve aims in the approved proposal starting 6 months and ending 36 months after publication of the study results.', 'accessCriteria': 'Data requests should be sent via email to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'sureyya gumussoy', 'investigatorAffiliation': 'Ege University'}}}}