- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06356168
Virtual Reality in End Stage Kidney Disease
Social Virtual Reality to Alleviate Loneliness and Symptoms for Individuals Receiving Hemodialysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lea Ann Matura, PhD
- Phone Number: 2157468819
- Email: matura@nursing.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Lea Ann Matura
- Phone Number: 713-410-1325
- Email: matura@nursing.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social Virtual Reality
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.
|
Participants interact using virtual reality during dialysis.
|
|
Active Comparator: Individual Virtual Reality
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.
|
Participants use virtual reality alone during dialysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
De Jong Gierveld Scale
Time Frame: Baseline and 4 Weeks
|
Measures how bad or severe a person's loneliness is.
Score range from 11-44; higher scores indicate more loneliness.
|
Baseline and 4 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lea Ann Matura, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- SVR/IVR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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