- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07644416
Using Virtual Reality Travel to Reduce Loneliness in Older Adults (VRT)
Virtual Reality Travel (VRT) as a Loneliness Intervention for Older Adults: A Pilot Randomized Controlled Trial
This study aims to investigate whether and how virtual reality travel (VRT) can reduce loneliness among older adults. It will utilize a mixed-methods research design that combines an randomly assigned experiment with follow-up semi-structured interviews.
This is a pilot study and it is essential to establish the feasibility and acceptability of the protocol, assess the tolerability of VR technology in this population prior to conducting a full-scale RCT, and generate preliminary effect size estimates to inform future sample size calculations.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruiping Ren
- Phone Number: 812-671-4087
- Email: renruip@iu.edu
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47401
- Evergreen Village at Bloomington
-
Contact:
- Sherri Ganka
- Phone Number: 812-336-2718
- Email: resident.services@evergreenvillage-bloomington.com
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Bloomington, Indiana, United States, 47408
- Bell Trace
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Contact:
- Melissa Davis
- Phone Number: 812-332-2355
- Email: mdavis@cardon.us
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Ellettsville, Indiana, United States, 47429
- Area 10 Agency on Aging
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Contact:
- Amy Guerrettaz
- Phone Number: 812-935-2582
- Email: aguerrettaz@area10agency.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 65 years or older
- Express willingness to engage with VR technology
Exclusion Criteria:
- No self-reported physical, sensory, neurological, or cognitive conditions that would make VR use unsafe or impractical (e.g., uncontrolled seizures, severe vertigo, or significant uncorrected vision/hearing impairments).
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: Virtual reality travel group
Participants in the VR travel group experience a 13-minute-and-44-second VR tour of Bali Island, Indonesia.
|
Participants in the VR travel group experience a 13-minute-and-44-second VR tour of Bali Island, Indonesia.
|
|
Active Comparator: Attention control group
Participants in the attention control group complete 13-minute-and-44-second symmetric puzzles featuring leaves, birds, and insects.
|
Participants in the attention control group complete 13 minutes and 44 seconds symmetric puzzles featuring leaves, birds, and insects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
loneliness
Time Frame: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
Loneliness was assessed using a multi-item visual analog scale (VAS), with items presented as 100 mm horizontal lines anchored by "Not at all" (left) and "Extremely" (right). Items were adapted from the University of California, Los Angeles Loneliness Scale and modified to capture present-moment experience using a "Right now…" stem, enabling assessment of state-level rather than trait-level loneliness. Participants were instructed to indicate their current feelings by placing a single perpendicular mark on each line corresponding to their response. VAS scores were calculated by measuring the distance in millimeters from the left anchor to the participant's mark, yielding a continuous score ranging from 0 to 100 for each item. Item scores were then averaged to compute an overall loneliness score, with higher values indicating higher levels of state loneliness. |
Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
positive emotions
Time Frame: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
Positive emotions was assessed using the Positive and Negative Affect Schedule (PANAS).
The PANAS consists of 20 items, including 10 items measuring positive affect (e.g., interested, excited, enthusiastic) and 10 items measuring negative affect (e.g., distressed, upset, nervous).
Participants were asked to indicate the extent to which they were experiencing each emotion right now on a Likert-type scale ranging from 1 (Very slightly or not at all) to 5 (Extremely), consistent with the state version of the measure.
Scores for positive affect and negative affect were computed separately by averaging the corresponding items, with higher scores indicating greater levels of the respective emotional state.
|
Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
|
meaning in life
Time Frame: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
Meaning in life was assessed using a modified version of the Multidimensional Existential Meaning Scale.
To capture state meaning in life, the phrase "right now" was added to each item to reflect participants' momentary perceptions.
The MEMS is a 15-item multidimensional measure based on a tripartite conceptualization of meaning in life encompassing comprehension (life coherence), purpose (goal-directedness), and mattering (perceived significance).
Participants rated each item on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree).
Each subscale consists of five items, and subscale scores were computed by averaging corresponding items, with one mattering item reverse scored.
Higher scores indicate greater levels of comprehension, purpose, and mattering.
|
Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- IUB-VRTPilot-2026
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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