Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT05695534
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of VR in Patients' Education Prior to Implantation of PPM
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-21', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of VR augmented eduacation assessed by a questionaire', 'timeFrame': '18 months', 'description': "A questionaire with questions assessing patients' personal experience and knowledge of the procedure was prepared. This will be collected and compared to patients with a standard education."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Education'], 'conditions': ['Pacemaker DDD']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.', 'detailedDescription': "The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior to implantation of a permanent pacemaker. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help patients to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures patients need to take after the procedure.\n\nPatients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patient needs to fullfill indication criteria for a pacemaker implantation -\n\nExclusion Criteria: Visual impairment\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05695534', 'briefTitle': "Use of VR in Patients' Education Prior to Implantation of PPM", 'organization': {'class': 'OTHER', 'fullName': 'Nemocnice AGEL Trinec-Podlesi a.s.'}, 'officialTitle': "Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker", 'orgStudyIdInfo': {'id': 'AGELTrinecPodlesi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard education', 'description': 'Patients will be educated about the procedure in a standard way by a docture and a nurse'}, {'type': 'EXPERIMENTAL', 'label': 'VR Education', 'description': 'Patients will be educated with the use of virtual reality', 'interventionNames': ['Other: VR educational video']}], 'interventions': [{'name': 'VR educational video', 'type': 'OTHER', 'description': 'Patients will be educated with our specifically made VR video in the settings of our hospital to make patients more familliar with the spaces and to explain them the procedure.', 'armGroupLabels': ['VR Education']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adéla Drozdová, MUDr.', 'role': 'CONTACT', 'email': 'drozdova.adela@gmail.com', 'phone': '+420607147489'}, {'name': 'Karin Poloková, MUDr.', 'role': 'CONTACT', 'email': 'kpolokova@gmail.com', 'phone': '+420607145057'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Only basic demographic data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adela Drozdova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Adela Drozdova', 'investigatorAffiliation': 'Nemocnice AGEL Trinec-Podlesi a.s.'}}}}