Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 12:37 PM
Study NCT ID:
NCT06985732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR
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': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHO-5', 'timeFrame': '4 times throughout of study at baseline and after each VR session', 'description': 'measure well-being. The score is between 0-100 a high score means better wellness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks.', 'detailedDescription': 'Patients meeting the inclusion criteria and agreeing to participate in the study will be enrolled and then randomized to either the VR immersion group or the control group. Patients included in the protocol will not undergo any changes to their care. Patients in the experimental group will receive 12 virtual reality sessions in addition to their usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeople hospitalized in the SMR unit at La Porte Verte Hospital for a minimum of 3 weeks,\n\n* People with preserved or slightly impaired cognitive status with an MMSE ≥ 20,\n* People who have been informed and have signed written informed consent\n\nExclusion Criteria:\n\nPeople under guardianship or curatorship,\n\n* People with difficulty understanding the VR study and materials,\n* People with vision problems that impact the use of VR,\n* People with hearing problems that impact the use of VR,\n* People with epilepsy,\n* People at risk of nausea and dizziness when using the VR headset,\n* People who cannot tolerate the VR headset,\n* Not affiliated with a social security scheme.\n* People receiving care with reflexology and relaxation massage'}, 'identificationModule': {'nctId': 'NCT06985732', 'acronym': 'RV-SMR', 'briefTitle': 'Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR', 'organization': {'class': 'OTHER', 'fullName': 'Centre Médical Porte Verte'}, 'officialTitle': 'Contribution of Virtual Reality to the Well-being of Elderly Patients Hospitalized in SMR', 'orgStudyIdInfo': {'id': '2025-A00983-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR group', 'interventionNames': ['Other: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'contrrol arm'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'OTHER', 'description': 'Use of virtual reality to elicit positive emotions and improve the well-being of elderly patients hospitalized in SMR', 'armGroupLabels': ['VR group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Baptiste ISABET', 'role': 'CONTACT', 'email': 'Baptiste.ISABET@lpv.univi.fr', 'phone': '0634227138', 'phoneExt': '0033'}, {'name': 'Fatima Zohra IZEDAREN', 'role': 'CONTACT', 'email': 'Fatima-Zohra.Izedaren@lpv.univi.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Médical Porte Verte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}