NCT05315609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 11, 2025

Status Verified

March 1, 2022

Enrollment Period

1 day

First QC Date

August 11, 2021

Last Update Submit

June 6, 2025

Conditions

Older AdultsStressMental Disorder

Keywords

Virtual realityMeditationMindfulnessStressOlder adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Other Outcomes (7)

  • Changes in symptoms of mindfulness skills

    Baseline, Once weekly during intervention

  • Qualitative Component: Participant observation, semi-structured interviews, and a focus group with participants.

    Post intervention (4-weeks)

  • Changes in simulator sickness as measured by the Simulator Sickness Questionnaire

    Baseline, Once weekly during intervention

  • +4 more other outcomes

Study Arms (2)

Intervention: Virtual Reality Mindfulness Group

EXPERIMENTAL

The intervention will be 4-weeks, twice per week, 15-minute/session VR-mindfulness intervention group.

Behavioral: VR Meditation

No intervention: Waitlist Control Group

NO INTERVENTION

These participants will be on a waitlist to receive the VR guided meditation program after data collection has been completed (after the 4 weeks)

Interventions

VR MeditationBEHAVIORAL

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.

Intervention: Virtual Reality Mindfulness Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Lady Davis Institute/ Jewish General Hospital

Montreal, Canada

Location

Related Publications (1)

  • Cinalioglu K, Lavin P, Bein M, Lesage M, Gruber J, Se J, Bukhari S, Sasi N, Noble H, Andree-Bruneau M, Launay C, Sanders J, Gauthier S, Rosa P, Lifshitz M, Battistini BJ, Beauchet O, Khoury B, Bouchard S, Fallavollita P, Vahia I, Rej S, Sekhon H. Effects of virtual reality guided meditation in older adults: the protocol of a pilot randomized controlled trial. Front Psychol. 2023 Jul 28;14:1083219. doi: 10.3389/fpsyg.2023.1083219. eCollection 2023.

    PMID: 37575420DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

August 11, 2021

First Posted

April 7, 2022

Study Start

April 30, 2022

Primary Completion

May 1, 2022

Study Completion

September 1, 2022

Last Updated

June 11, 2025

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)