- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580352
Assessing the Feasibility of Using Virtual Reality Experiences in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Significance
Seriously ill older adults frequently harbor unfulfilled end-of-life aspirations, commonly referred to as "bucket list" experiences. Advanced illness, functional decline, and the constraints of institutional living typically render travel and other real world experiences largely unattainable for this population. Virtual reality (VR) technology, now widely commercially available, may offer an accessible means of delivering immersive surrogate experiences at the bedside. However, the feasibility of VR engagement among seriously ill nursing home residents - including their capacity to tolerate head-mounted display use, sustain attention during immersion, and derive meaningful benefit - has not been adequately established. The present study seeks to address this gap.
Specific Aims:
- To determine the feasibility of administering immersive VR experiences to seriously ill older adult nursing home residents using a commercially available head-mounted display.
- To compare participant ability to tolerate two distinct VR delivery modalities: computer-generated virtual reality (CG-VR) and film-based virtual reality (FB-VR).
- To explore, through qualitative inquiry, participant perceptions of VR as a vehicle for fulfilling personally meaningful experiences (virtual bucket-listing).
Study Design
This is a feasibility study employing a randomized, two-arm parallel-group design with an optional crossover component and embedded qualitative interviews.
Study Population: Seriously ill older adult residents of the participating nursing home facility.
Study Procedures
Following written informed consent, each participant will be invited to articulate a personal bucket list. Participants who identify one or more bucket list items will be randomly assigned in a 1:1 ratio to one of two arms:
- Arm A: A three-minute immersive waterfall experience delivered via CG-VR.
- Arm B: A three-minute immersive waterfall experience delivered via FB-VR. All VR content will be delivered using the Meta Quest Pro head-mounted display. Following the initial experience, participants will be offered the option to engage in a second VR session - either the alternate modality (CG-VR or FB-VR) or an alternative VR environment of personal significance to the participant.
Outcome Measures:
Primary outcomes (feasibility): Consent, completion of the assigned VR experience, and adverse events (including cybersickness, agitation, or discomfort).
Secondary outcomes:
- Change in symptom burden as measured by pre- and post-experience scores on the Edmonton Symptom Assessment System-Revised (ESAS-r).
- Participant-reported relaxation ratings obtained immediately following the VR experience.
- Qualitative data derived from post-experience semi-structured interviews for thematic analysis.
Risks and Anticipated Benefits:
Risks are anticipated to be minimal and primarily limited to transient cybersickness, mild disorientation, or emotional response to the experiential content. Participants may benefit from symptom relief, relaxation, and engagement with personally meaningful imagery, although direct benefit is not assured. Findings will inform the design of subsequent efficacy trials evaluating VR as a palliative intervention.
Statistical Considerations:
Given that this is a feasibility pilot study, there is no hypothesis testing and the study is not powered to detect efficacy.Descriptive statistics will be employed to characterize feasibility metrics and outcome distributions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Seriously ill nursing home residents identified by their care team as able to participate.
-
Exclusion Criteria: <65 years of age
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Computer-generated VR waterfalls
This is a computer-generated VR waterfalls
|
Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
|
|
Active Comparator: Film-based VR waterfalls
This is a film-based VR waterfalls
|
Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edmonton Symptom Assessment Scale (ESASr)
Time Frame: Baseline
|
ESAS-r assessed nine common symptoms (Pain, Fatigue, Nausea, Depression, Anxiety, Drowsiness, Shortness of Breath, Appetite, and Wellbeing) on 0-10 scales.
(cite) A sleep item was also included.
|
Baseline
|
|
Relaxation scale
Time Frame: Immediately before and after the 3-minute VR exposure.
|
Relaxation was assessed with a single item (0 = not relaxed at all; 10 = extremely relaxed)
|
Immediately before and after the 3-minute VR exposure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 67522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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