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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Adapted Virtual Reality Mindfulness Meditation Program
DeviceImmersive Virtual Reality Mindfulness Meditation
Usual Care
Other interventionStandard Care
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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
Secondary outcomes
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.