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

Condition(s) studied

Investigational drug(s) / intervention(s)

Adapted Virtual Reality Mindfulness Meditation Program: Immersive Virtual Reality Mindfulness Meditation

Usual Care: Standard Care

Study 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 Toujours Dimanche virtual reality mindfulness meditation program 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

Eligibility

Primary outcome measure(s)

• Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators — Up to 4 weeks
  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.
• Acceptability of the Intervention — At 4 weeks
  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.
• Change in Depression Symptoms — Baseline and 4 weeks
  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.
• Change in Anxiety Symptoms — Baseline and 4 weeks
  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

Trial sites (2)

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