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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorLaval University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Recurrent migraines

Epilepsy

Traumatic brain injury during the past year

Glaucoma or recovery from eye surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted Virtual Reality Mindfulness Meditation Program

    Device

    Immersive Virtual Reality Mindfulness Meditation

  • Usual Care

    Other intervention

    Standard Care

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Adapted Toujours Dimanche Virtual Reality MeditationExperimental treatment 2 interventions
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 4 weeks
2

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.

Time frame
At 4 weeks
3

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.

Time frame
Baseline and 4 weeks
4

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

Time frame
Baseline and 4 weeks

Secondary outcomes

1

Change in Quality of Life

Quality of life will be assessed using the Quality of Life in Alzheimer's Disease Scale Nursing Home version (QoL-AD-NH), completed by the resident when possible and/or by a caregiver proxy. The QoL-AD-NH includes 13 items assessing key life domains, such as physical health, mood, memory, relationships, and finances. Each item is scored on a 4-point scale: 1 = poor, 2 = fair, 3 = good, and 4 = excellent. Total scores range from 13 to 52, with higher scores indicating better quality of life. Scores from 40 to 52 indicate high quality of life, scores from 27 to 39 indicate moderate quality of life, and scores from 13 to 26 indicate low quality of life.

Time frame
Baseline and 4 weeks

Other outcomes

1

Change in Self-Reported Pain Intensity

Self-reported pain intensity will be assessed using the Numeric Rating Scale (NRS), completed by the resident when possible. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

Time frame
Baseline and 4 weeks
2

Change in Observed Pain

Observed pain will be assessed using the Pain Assessment in Advanced Dementia Scale (PAIN-AD), completed by a staff member. The PAIN-AD includes 5 observed behavioral indicators, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating more pain-related behaviors. A score of 0 indicates no observed pain-related behavior; scores from 1 to 3 may indicate mild pain; scores from 4 to 6 may indicate moderate pain; and scores from 7 to 10 may indicate severe pain.

Time frame
Baseline and 4 weeks
3

Change in Loneliness

Loneliness will be assessed using the UCLA Loneliness Scale short form (ULS-6), completed by the resident when possible. The ULS-6 includes 6 items. Total scores range from 6 to 24, with higher scores indicating greater loneliness.

Time frame
Baseline and 4 weeks
4

Change in Social Engagement

Social engagement will be assessed using the Engagement of a Person with Dementia Scale (EPWDS), completed by a staff member. The EPWDS includes 10 items assessing affective, visual, verbal, behavioral, and social engagement. Each item is scored on a 1-to-5 scale, with some items reverse scored. Total scores range from 10 to 50. Higher scores indicate greater positive engagement, while lower scores indicate greater disengagement or negative engagement.

Time frame
Baseline and 4 weeks

Sponsors and contacts

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Laval University

Lead sponsor

McGill University

Collaborator

Université de Sherbrooke

Collaborator