Effects of Virtual Reality Meditation in Older Adults

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05315609
• Other study ID #: IUSMD-21-48
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Lady Davis Institute
• Contact: Paola Lavín
• Phone: 5147616131
• Email: maria.lavingonzalez[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Older Adults
• Stress

Intervention

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.

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montréal	Quebec
Canada	Lady Davis Institute/ Jewish General Hospital	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Country where clinical trial is conducted

Canada, 

Outcome

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