Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT06356168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in End Stage Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'De Jong Gierveld Scale', 'timeFrame': 'Baseline and 4 Weeks', 'description': "Measures how bad or severe a person's loneliness is. Score range from 11-44; higher scores indicate more loneliness."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks.', 'detailedDescription': 'In a single site, 2-arm (Social Virtual Reality group; Individual Virtual Reality Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Social Virtual Reality to Individual Virtual Reality on symptoms in participants with end stage kidney disease who are receiving hemodialysis.\n\nTo compare the effects of social virtual reality to individual virtual reality on loneliness To explore the effects of social virtual reality to individual virtual reality on anxiety and depression.\n\nTo compare the effects social virtual reality to individual virtual reality on quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosis of end stage kidney disease with hemodialysis 3 times per week for at least 1 month\n\nExclusion Criteria\n\n* Acutely ill\n* Active nausea\n* Epilepsy'}, 'identificationModule': {'nctId': 'NCT06356168', 'briefTitle': 'Virtual Reality in End Stage Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Social Virtual Reality to Alleviate Loneliness and Symptoms for Individuals Receiving Hemodialysis', 'orgStudyIdInfo': {'id': 'SVR/IVR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Virtual Reality', 'description': 'Social Virtual Reality will be delivered using virtual reality glasses for 30-45 minutes during dialysis sessions. Groups of 3 participants will watch a movie or program together through the glasses. They will be able to talk and interact during the session.', 'interventionNames': ['Behavioral: Social Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Virtual Reality', 'description': 'Individual Virtual Reality will be delivered using virtual reality glasses for 30-45 minutes during dialysis sessions. Those randomized to this arm will watch a movie or program alone through the glasses.', 'interventionNames': ['Behavioral: Individual Virtual Reality']}], 'interventions': [{'name': 'Social Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Participants interact using virtual reality during dialysis.', 'armGroupLabels': ['Social Virtual Reality']}, {'name': 'Individual Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Participants use virtual reality alone during dialysis.', 'armGroupLabels': ['Individual Virtual Reality']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lea Ann Matura, PhD', 'role': 'CONTACT', 'email': 'matura@nursing.upenn.edu', 'phone': '2157468819'}], 'overallOfficials': [{'name': 'Lea Ann Matura, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}