- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315609
Effects of Virtual Reality Meditation in Older Adults
Effects of Virtual Reality Meditation in Older Adults: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montréal, Canada
- Lady Davis Institute/ Jewish General Hospital
-
-
Quebec
-
Montréal, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Living in the Greater Montreal area and able to speak English or French
- Perceived Stress Score (PSS)equal or greater than 10
- Over >=60 years of age
Exclusion Criteria:
- Diagnosis of epilepsy, schizophrenia, brain tumor
- History of recurrent migraines or seizures or TBI in the past year
- Substance use disorders in the last year
- Psychiatric hospitalizations in the last year.
- Acute psychotic symptoms
- Acute suicidal ideation or intent
- Glaucoma
- PTSD
- Changes to psychoactive medications in the past 4 weeks
- Alcohol, caffeine or cannabis consumption within 24 hr before the session, or nicotine consumption within 15 min of the session
- Important hearing impairment
- Recovery phase of any eye surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention: Virtual Reality Mindfulness Group
The intervention will be 4-weeks, twice per week, 15-minute/session VR-mindfulness intervention group.
|
This 4-week VR program will use the Oculus Pro-Quest 2 headsets for the 15-minute seated VR meditation twice per week for a total of 8 sessions over the 4 weeks.
|
|
No Intervention: No intervention: Waitlist Control Group
These participants will be on a waitlist to receive the VR guided meditation program after data collection has been completed (after the 4 weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
Time Frame: Baseline, Once weekly during intervention
|
To assess the effectiveness of the virtual reality meditation program in reducing stress in older adults. Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress. |
Baseline, Once weekly during intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire for treatment group versus control group
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on symptoms of anxiety in older adults. Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety. |
Baseline, Once weekly during intervention
|
|
Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on symptoms of depression in older adults. Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression. |
Baseline, Once weekly during intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in symptoms of mindfulness skills
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on mindfulness skills in older adults. Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) is a 24-item scale that is used to assess whether mindfulness is related to a decrease in clinical symptoms of depression, anxiety, and stress. |
Baseline, Once weekly during intervention
|
|
Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants.
Time Frame: Post intervention (4-weeks)
|
Qualitative interviews to examine users' experience of the virtual reality meditation program. We will conduct qualitative evaluations through participant observation and semi-structured interviews and a focus group with participants. The qualitative part of the study will analyze service users' experience, engagement, and challenges throughout the study. Participant observation will be used to provide a context for the interviews. It will also help to observe clients' engagement, usage, expressions, physical movements, and barriers. |
Post intervention (4-weeks)
|
|
Changes in simulator sickness as measured by the Simulator Sickness Questionnaire
Time Frame: Baseline, Once weekly during intervention
|
To assess participants' acceptability of the virtual reality guided meditation program. Simulator Sickness Questionnaire is a 16-item scale that is widely used to assess simulator sickness. |
Baseline, Once weekly during intervention
|
|
Changes in loneliness sentiments as measured by the University of California-3 (UCLA-3) item loneliness questionnaire
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on feelings of loneliness measured through the University of California-3 (UCLA 3-item) loneliness scale. The Three-Item Loneliness Scale is an interviewer-administered questionnaire developed from the Revised UCLA Loneliness Scale. Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score. Higher scores indicate greater feelings of loneliness |
Baseline, Once weekly during intervention
|
|
Changes in symptoms of sleep quality as measured by the Athens Insomnia Scale (AIS)
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on sleep quality in older adults. Each item is rated on a 4-point numerical rating scale (NRS; where 0= no problem at all and 3= very serious problem). Total scores range from 0 to 24 in the AIS-8 and from 0 to 15 in the AIS-5. Higher scores in these AIS measures indicate that responders have severe insomnia symptoms. |
Baseline, Once weekly during intervention
|
|
Changes in symptoms of quality of life in older adults as measured by the European Quality of Life (Euro-QoL) measure.
Time Frame: Baseline, Once weekly during intervention
|
To assess the effects of the virtual reality meditation program on quality of life in older adults. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time (McDowell & Newell, 1996). |
Baseline, Once weekly during intervention
|
|
Changes in sense of presence as measured by the ITC-Sense of Presence Inventory
Time Frame: Baseline, Once weekly during intervention
|
The ITC-Sense of Presence Inventory is a self-report presence measure to evaluate experiential aspects of immersive technology.
|
Baseline, Once weekly during intervention
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUSMD-21-48
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
product manufactured in and exported from the U.S.
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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