NCT06356168

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026May 2027

First Submitted

Initial submission to the registry

March 28, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

March 28, 2024

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Social Virtual Reality

EXPERIMENTAL

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.

Behavioral: Social Virtual Reality

Individual Virtual Reality

ACTIVE COMPARATOR

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.

Behavioral: Individual Virtual Reality

Interventions

Participants interact using virtual reality during dialysis.

Social Virtual Reality

Participants use virtual reality alone during dialysis.

Individual Virtual Reality

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of end stage kidney disease with hemodialysis 3 times per week for at least 1 month

You may not qualify if:

  • Acutely ill
  • Active nausea
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lea Ann Matura, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Ann Matura, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 10, 2024

Study Start

January 15, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share