Clinical trial NCT05315609: 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
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Stress
Mental Disorder
Keywords: Virtual reality
Meditation
Mindfulness
Stress
Older adults
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
timeFrame: Baseline, Once weekly during intervention
Secondary outcomes:
measure: Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire for treatment group versus control group
timeFrame: Baseline, Once weekly during intervention
measure: Changes in symptoms of depression as measured by the Patient Health Questionnaire-9 (PHQ-9) scale for treatment group versus control group
timeFrame: Baseline, Once weekly during intervention
Other outcomes:
measure: Changes in symptoms of mindfulness skills
timeFrame: Baseline, Once weekly during intervention
measure: Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants.
timeFrame: Post intervention (4-weeks)
measure: Changes in simulator sickness as measured by the Simulator Sickness Questionnaire
timeFrame: Baseline, Once weekly during intervention
measure: Changes in loneliness sentiments as measured by the University of California-3 (UCLA-3) item loneliness questionnaire
timeFrame: Baseline, Once weekly during intervention
measure: Changes in symptoms of sleep quality as measured by the Athens Insomnia Scale (AIS)
timeFrame: Baseline, Once weekly during intervention
measure: Changes in symptoms of quality of life in older adults as measured by the European Quality of Life (Euro-QoL) measure.
timeFrame: Baseline, Once weekly during intervention
measure: Changes in sense of presence as measured by the ITC-Sense of Presence Inventory
timeFrame: Baseline, Once weekly during intervention
Locations:
city: Montréal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
city: Montréal
country: Canada
facility: Lady Davis Institute/ Jewish General Hospital
Study officials:
References: