Immersive Virtual Reality for Older Adults in Long-Term Care Settings

NCT07658287 | Not Yet Recruiting

• 1 other identifier: MP-23-2024-1086
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if an immersive virtual reality mindfulness meditation program is feasible and acceptable for older adults living in long-term care settings in Quebec who have mild to moderate neurocognitive disorder. It will also learn about the safety and potential effects of the program on well-being. The main questions it aims to answer are:

• Is the virtual reality mindfulness meditation program feasible and acceptable for residents and staff in long-term care settings?
• Does the adapted version of the program show potential benefits for well-being, including depression, anxiety, quality of life, mindfulness, pain, and loneliness?
• What practical challenges, user experiences, and side effects, such as cybersickness, occur during the program? Researchers will compare the original Toujours Dimanche virtual reality mindfulness meditation program, an adapted version of Toujours Dimanche designed for older adults with mild to moderate neurocognitive disorder, and standard care alone to see if the adapted program is feasible, acceptable, and potentially helpful. Participants will:
• Take part in up to 8 virtual reality mindfulness meditation sessions over 4 weeks, if assigned to a virtual reality group
• Complete questionnaires before and after the 4-week study period
• Share feedback about their experience, when possible
• Be observed by staff or research team members to document feasibility, acceptability, user experience, and safety

Conditions

Cognitive Impairment; Long-term Care Centres for Old Adults Users

Keywords

Virtual Reality; Mindfulness Meditation; Long-Term Care; Older Adults; Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators

  Feasibility will be assessed descriptively using feasibility indicators recommended by Thabane et al. for pilot studies. These indicators will include recruitment feasibility, assessed by the recruitment rate; intervention completion, assessed through adherence to planned sessions and attrition/retention rates; blinding feasibility, assessed through the effectiveness of blinding procedures; potential risks, assessed through the number, type, frequency, and severity of adverse events; and practical implementation challenges requiring modification of the intervention or study procedures. Reference: Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology. 2010;10(1):1-10.

  Up to 4 weeks

• Acceptability of the Intervention

  Acceptability will be assessed from the perspectives of residents and staff using a researcher-developed acceptability questionnaire designed specifically for this study. The questionnaire includes 1-to-7 visual analogue scales and open-ended questions about the virtual reality mindfulness meditation program. For the 1-to-7 scales, the minimum value is 1 and the maximum value is 7, with higher scores indicating greater acceptability of the intervention. Open-ended responses will be summarized descriptively to document participants' and staff members' perceptions, comments, and suggestions.

  At 4 weeks

• Change in Depression Symptoms

  Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 27. Higher scores indicate greater depression symptom severity.

  Baseline and 4 weeks

• Change in Anxiety Symptoms

  Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 item scale (GAD-7), completed by the resident when possible and/or by a staff member using an observer-rated version. Total scores range from 0 to 21. Higher scores indicate greater anxiety symptom severit

  Baseline and 4 weeks

Secondary Outcomes (1)

• Change in Quality of Life

  Baseline and 4 weeks

Other Outcomes (6)

• Change in Self-Reported Pain Intensity

  Baseline and 4 weeks

• Change in Observed Pain

  Baseline and 4 weeks

• Change in Loneliness

  Baseline and 4 weeks

Study Arms (3)

Guided Mindfulness Meditation

EXPERIMENTAL

Participants in this group will receive standard care and guided mindfulness meditation sessions designed for people with cognitive impairment. Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes, depending on participant preferences, comfort, and tolerance.

Behavioral: Guided Mindfulness Meditation; Other: Usual Care

Adapted Toujours Dimanche Virtual Reality Meditation

EXPERIMENTAL

Participants in this group will receive standard care and the adapted Toujours Dimanche immersive virtual reality program. The intervention includes guided mindfulness meditation sessions designed for older adults with mild to moderate cognitive impairment or neurocognitive disorder. Participants will be invited to complete 8 sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes.

Device: Adapted Virtual Reality Mindfulness Meditation Program; Other: Usual Care

Standard Care

ACTIVE COMPARATOR

Participants in this group will receive standard care alone for 4 weeks. They will not receive the guided mindfulness meditation intervention or the Toujours Dimanche virtual reality meditation program during the study period.

Other: Usual Care

Interventions

Guided Mindfulness Meditation BEHAVIORAL

Mindfulness Meditation for Cognitive Impairment

Guided Mindfulness Meditation

Adapted Virtual Reality Mindfulness Meditation Program DEVICE

Immersive Virtual Reality Mindfulness Meditation

Adapted Toujours Dimanche Virtual Reality Meditation

Usual Care OTHER

Standard Care

Adapted Toujours Dimanche Virtual Reality Meditation; Guided Mindfulness Meditation; Standard Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For resident participants:
• Resident of a participating long-term care facility, seniors' home, or alternative seniors' home in the Chaudière-Appalaches or Capitale-Nationale regions of Quebec
• Aged 60 years or older
• Able to understand French or English
• Able to provide informed consent or assent, or have consent provided by a legally authorized representative or person authorized to consent
• Mild to moderate cognitive impairment or neurocognitive disorder
• Normal or corrected vision and hearing
• For staff participants:
• Regularly works with at least one resident participating in Phase 3
• Has completed the revised virtual reality training provided by Super Splendide and/or Martine Bordeleau

You may not qualify if:

• For resident participants:
• Recurrent migraines
• Epilepsy
• Traumatic brain injury during the past year
• Glaucoma or recovery from eye surgery
• Diagnosed uncontrolled epilepsy
• Diagnosed severe vertigo
• Severe hearing impairment without a corrective hearing device
• Significant visual impairment that would prevent use of a virtual reality headset
• Motion sickness that would prevent use of a virtual reality headset
• Any health condition that restricts movement or prevents safe participation, such as a significant reduction in neck or upper-limb range of motion

Sponsors & Collaborators

• Laval University: lead
• McGill University: collaborator
• Université de Sherbrooke: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maude Laberge, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Bordeleau, PhD

CONTACT

581-490-2626; martine.bordeleau@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used. Participants, care providers, investigators, and outcome assessors may be aware of group assignment because the intervention involves visible virtual reality equipment and is delivered in real-world long-term care settings.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be allocated to one of three parallel groups for a 4-week study period: standard care with guided mindfulness meditation sessions, standard care with the adapted Toujours Dimanche immersive virtual reality mindfulness meditation program, or standard care alone. Participants will remain in their assigned group throughout the study.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06