Back to resultsEffects of Virtual Reality Meditation in Older Adults
Primary Purpose
Older Adults, Stress, Mental Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VR Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Older Adults focused on measuring Virtual reality, Meditation, Mindfulness, Stress, Older adults
Eligibility Criteria
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
Sites / Locations
- Douglas Mental Health University Institute
- Lady Davis Institute/ Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention: Virtual Reality Mindfulness Group
No intervention: Waitlist Control Group
Arm Description
The intervention will be 4-weeks, twice per week, 15-minute/session VR-mindfulness intervention 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)
Outcomes
Primary Outcome Measures
Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
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.
Secondary Outcome Measures
Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire for treatment group versus control group
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.
Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05315609
Brief Title
Effects of Virtual Reality Meditation in Older Adults
Official Title
Effects of Virtual Reality Meditation in Older Adults: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Virtual reality (VR) allows users to interact within a simulated environment using electronic devices such as a VR headset or goggles. Multiple studies with younger adults have demonstrated that VR meditation can be an important tool in reducing stress, however, this has not been studied in older adults. In this study, the investigators aim to assess the effects of a 4-week program of 15-minutes sessions, twice per week of meditation delivered through VR with the aim of evaluating its impact on stress in older adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adults, Stress, Mental Disorder
Keywords
Virtual reality, Meditation, Mindfulness, Stress, Older adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Virtual Reality Mindfulness Group
Arm Type
Experimental
Arm Description
The intervention will be 4-weeks, twice per week, 15-minute/session VR-mindfulness intervention group.
Arm Title
No intervention: Waitlist Control Group
Arm Type
No Intervention
Arm Description
These participants will be on a waitlist to receive the VR guided meditation program after data collection has been completed (after the 4 weeks)
Intervention Type
Behavioral
Intervention Name(s)
VR Meditation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
Description
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.
Time Frame
Baseline, Once weekly during intervention
Secondary Outcome Measure Information:
Title
Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire for treatment group versus control group
Description
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.
Time Frame
Baseline, Once weekly during intervention
Title
Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group
Description
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.
Time Frame
Baseline, Once weekly during intervention
Other Pre-specified Outcome Measures:
Title
Changes in symptoms of mindfulness skills
Description
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.
Time Frame
Baseline, Once weekly during intervention
Title
Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants.
Description
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.
Time Frame
Post intervention (4-weeks)
Title
Changes in simulator sickness as measured by the Simulator Sickness Questionnaire
Description
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.
Time Frame
Baseline, Once weekly during intervention
Title
Changes in loneliness sentiments as measured by the University of California-3 (UCLA-3) item loneliness questionnaire
Description
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
Time Frame
Baseline, Once weekly during intervention
Title
Changes in symptoms of sleep quality as measured by the Athens Insomnia Scale (AIS)
Description
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.
Time Frame
Baseline, Once weekly during intervention
Title
Changes in symptoms of quality of life in older adults as measured by the European Quality of Life (Euro-QoL) measure.
Description
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).
Time Frame
Baseline, Once weekly during intervention
Title
Changes in sense of presence as measured by the ITC-Sense of Presence Inventory
Description
The ITC-Sense of Presence Inventory is a self-report presence measure to evaluate experiential aspects of immersive technology.
Time Frame
Baseline, Once weekly during intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Lavín
Phone
5147616131
Ext
3330
Email
maria.lavingonzalez@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Cinalioglu
Phone
5145508683
Email
karin.cinalioglu@mail.mcgill.ca
Facility Information:
Facility Name
Douglas Mental Health University Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Lavin, MD,MSc
Email
maria.lavingonzalez@mail.mcgill.ca
Facility Name
Lady Davis Institute/ Jewish General Hospital
City
Montréal
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Cinalioglu, BA
Email
karin.cinalioglu@mail.mcgill.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Virtual Reality Meditation in Older Adults
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