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NCT06356168 Clinical Trial

Virtual Reality in End Stage Kidney Disease

End Stage Kidney Disease Clinical Trial

Official title:
Social Virtual Reality to Alleviate Loneliness and Symptoms for Individuals Receiving Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06356168
Other study ID # SVR/IVR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date January 31, 2025

Study information
Verified date June 2024
Source University of Pennsylvania
Contact Lea Ann Matura, PhD
Phone 2157468819
Email matura@nursing.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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. To 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. To compare the effects social virtual reality to individual virtual reality on quality of life.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date January 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria - Diagnosis of end stage kidney disease with hemodialysis 3 times per week for at least 1 month Exclusion Criteria - Acutely ill - Active nausea - Epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Social Virtual Reality
Participants interact using virtual reality during dialysis.
• Individual Virtual Reality
Participants use virtual reality alone during dialysis.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Outcome
Type Measure Description Time frame Safety issue
Primary De Jong Gierveld Scale Measures how bad or severe a person's loneliness is. Score range from 11-44; higher scores indicate more loneliness. Baseline and 4 Weeks
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