Effects of Virtual Reality Meditation in Older Adults

Sponsor

Lady Davis Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05315609

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Older Adults Stress Mental Disorder	Behavioral: VR Meditation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Virtual Reality Meditation in Older Adults: A Randomized Controlled Trial

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.	Behavioral: VR Meditation 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)

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.

Behavioral: VR Meditation

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)

Outcome Measures

Primary Outcome Measures

Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group [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.

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 [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.
Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group [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.

Other Outcome Measures

Changes in symptoms of mindfulness skills [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.
Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants. [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.
Changes in simulator sickness as measured by the Simulator Sickness Questionnaire [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.
Changes in loneliness sentiments as measured by the University of California-3 (UCLA-3) item loneliness questionnaire [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
Changes in symptoms of sleep quality as measured by the Athens Insomnia Scale (AIS) [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.
Changes in symptoms of quality of life in older adults as measured by the European Quality of Life (Euro-QoL) measure. [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).
Changes in sense of presence as measured by the ITC-Sense of Presence Inventory [Baseline, Once weekly during intervention]
The ITC-Sense of Presence Inventory is a self-report presence measure to evaluate experiential aspects of immersive technology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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