Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-02 @ 12:54 PM
Study NCT ID:
NCT04840732
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Application in Chemotherapy Administration in Nurse Staff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator and Outcomes Assessor blind'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Knowledge and attitude (pre test)', 'timeFrame': 'baseline data', 'description': 'Chemotherapy knowledge and attitude, range 5-50, higer score means higher attitude to do chemotherapy'}], 'primaryOutcomes': [{'measure': 'Objective Structured Clinical Examination score (OSCE score)', 'timeFrame': 'One month', 'description': 'One month after intervention, we assess the OSCE score from participates, range from 0 to 100, higher score means better grade.'}], 'secondaryOutcomes': [{'measure': 'Self-assessment skill score', 'timeFrame': 'One month', 'description': 'The confidence of Self-assessment skill score after intervention. Range from 0 to 100, higher score means better grade.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D virtual reality', 'administration'], 'conditions': ['Chemotherapy Training']}, 'referencesModule': {'references': [{'pmid': '35795629', 'type': 'DERIVED', 'citation': 'Wang CY, Lu CY, Yang SY, Tsai SC, Huang TW. 3D Virtual Reality Smartphone Training for Chemotherapy Drug Administration by Non-oncology Nurses: A Randomized Controlled Trial. Front Med (Lausanne). 2022 Jun 20;9:889125. doi: 10.3389/fmed.2022.889125. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The present study wants to design a training program for chemotherapy with using VR among nurse staff. Then the investigators design a protocol to compare the training effects in the VR program and ISO document.', 'detailedDescription': 'As technology advances, mobile devices have gradually turned into wearable devices. Furthermore, virtual reality (VR), augmented reality (AR), and mixed reality (MR) are being increasingly applied in medical fields such as medical education and training, surgical simulation, neurological rehabilitation, psychotherapy, and telemedicine. Research results demonstrate the ability of VR, AR, and MR to ameliorate the inconveniences that are often associated with traditional medical care, reduce incidents of medical malpractice caused by unskilled operations, and reduce the cost of medical education and training. What is more, the application of these technologies has enhanced the effectiveness of medical education and training, raised the level of diagnosis and treatment, improved the doctor-patient relationship, and boosted the efficiency of medical execution. The present study wants to design a training program for chemotherapy with using VR. Then the investigators design a protocol to compare the training effects in VR program and ISO document.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The staffs who require to implement chemotherapy skill in the hospital. Age over 20 years.\n\nExclusion Criteria:\n\n* Refuse to join the study.'}, 'identificationModule': {'nctId': 'NCT04840732', 'briefTitle': 'Virtual Reality Application in Chemotherapy Administration in Nurse Staff', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Virtual Reality Application in Chemotherapy Administration in Nurse Staff', 'orgStudyIdInfo': {'id': 'VR for nurse'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Intervention', 'description': 'The experimental group uses the VR program to training chemotherapy skill. Use VR software to make a training education program.', 'interventionNames': ['Behavioral: VR training program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Intervention: usual care', 'description': 'Chemotherapy training as usual care (for training chemotherapy skill).', 'interventionNames': ['Behavioral: usual care']}], 'interventions': [{'name': 'VR training program', 'type': 'BEHAVIORAL', 'description': 'Use VR software to make a training education program.', 'armGroupLabels': ['Experimental: Intervention']}, {'name': 'usual care', 'type': 'BEHAVIORAL', 'description': 'Chemotherapy training as usual care (for training chemotherapy skill).', 'armGroupLabels': ['No Intervention: usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei County', 'country': 'Taiwan', 'facility': 'Taipei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}