NCT05466123

Brief Summary

The purpose of this study is to assess whether virtual reality technology can reduce anxiety, depression, and emotional distress screening scores in palliative care patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress97%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

July 15, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

July 15, 2022

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in anxiety

    Measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Subjects rank how often they have been bother by specific problems within the last 2 weeks on a scale of 0 being not at all and 3 being nearly every day. Total scores range from 0-20, with higher scores indicating more anxiety severity.

    Baseline, post-intervention approximately 30 minutes

  • Change in emotional distress

    Measured using the self-reported Distress from Death and Dying Survey. Subjects rank their distress on a scale or 0-10, 0 being no distress at all, and 10 being completely distressed. Total scores range from 0-130, with higher scores indicating more distress severity.

    Baseline, post-intervention approximately 30 minutes

Study Arms (1)

Virtual reality intervention in palliative care patients

EXPERIMENTAL

Palliative care patients with a limited life expectancy will participate in a virtual reality experience for 10-30 minutes

Behavioral: Virtual Reality

Interventions

Virtual RealityBEHAVIORAL

Simulated travel destination or activity of the participants choosing that would otherwise be inaccessible

Virtual reality intervention in palliative care patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A terminal or end-stage condition with an expected prognosis of a year or less.
  • An established palliative care patient.
  • English-speaking.
  • Able to wear virtual reality equipment (goggles, etc.).
  • Subject or Caregiver able to provide consent.

You may not qualify if:

  • Younger than 18 years of age.
  • Lack of a prognosis of approximately 1 year or less.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Chimere Bruning, PA-C

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 20, 2022

Study Start

November 9, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations