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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This pilot feasibility trial will evaluate the use of a mindfulness meditationintervention delivered with or without the Toujours Dimanche immersive virtual realityapplication in long‐term care settings in Quebec. The study will be conducted with olderadults living in long‐term care facilities, seniors' homes, and alternative seniors'homes in the Chaudière‐Appalaches and Capitale‐Nationale regions who have mild tomoderate cognitive impairment or neurocognitive disorder.The pilot phase will use a randomized experimental design. The purpose of this phase isto evaluate the feasibility, acceptability, safety, user experience, and preliminaryeffects of the intervention in real‐world long‐term care settings. This phase will alsohelp identify practical issues related to time management, human resources, datacollection, and intervention delivery before a future larger‐scale effectiveness trial.A total of 36 residents will be recruited. This sample size is based on recommendationsfor feasibility studies, with 12 participants per group. Staff members who regularly workwith participating residents and who have completed virtual reality training throughSuper Splendide and/or Martine Bordeleau will also be recruited. These staff members willdeliver the intervention and provide feedback on its feasibility and acceptability.Residents who meet the inclusion and exclusion criteria will be assigned to one of threegroups. Group A will receive standard care and guided mindfulness meditation sessionsdesigned for people with cognitive impairment. Group B will receive standard care and theadapted version of the Toujours Dimanche program, which includes guided mindfulnessmeditation sessions designed for people with cognitive impairment. Group C will receivestandard care for four weeks.Allocation to the groups will be performed using minimization, a method recognized as anacceptable alternative to randomization when the sample size is small. The allocationprocedure will consider sex, gender, and age group. The study coordinator will haveaccess to participants' group allocation. The long‐term care team will plan theintervention sessions and inform the study coordinator of the selected dates and times.Participants in Groups A and B will be invited to complete 8 mindfulness meditationsessions over 4 consecutive weeks, with approximately 2 sessions per week. Each sessionwill last about 5 to 15 minutes, depending on the participant's preferences, comfort, andtolerance. The sessions will be delivered by trained staff members who know theparticipating residents well. Sessions will take place in the resident's room.Participants may stop a session at any time.Data will be collected from residents and staff members when possible. If a resident hasdifficulty communicating verbally or through gestures, the staff member who knows theresident best may provide responses using observer‐rated versions of the questionnaires.Sociodemographic information will be collected at baseline. Feedback on the program willbe collected after the 4‐week study period from residents, when possible, and from staffmembers.Feasibility outcomes will include recruitment, adherence, attrition, interventioncompletion, and practical challenges encountered during implementation. Acceptabilitywill be assessed from the perspectives of residents and staff using researcher‐developedquestions, including visual analogue scales and open‐ended questions. User experience,perceived presence, potential risks, side effects, and other practical issues will alsobe documented.Preliminary clinical outcomes will be assessed before the beginning of the interventionand after the end of the 4‐week period. The primary clinical outcomes are depression andanxiety. Quality of life will be assessed as a secondary outcome. Mindfulness, pain, andloneliness will be assessed as tertiary or exploratory outcomes. Measures will beadministered in a predefined order, beginning with depression and anxiety, followed byquality of life, and then the exploratory outcomes. If a participant shows signs ofexcessive fatigue or reduced motivation, data collection may be paused or stopped.Because the study includes residents with cognitive impairment, consent and assentprocedures will be adapted to protect residents' rights, comfort, and dignity. Whenresidents are able to provide informed consent, consent will be obtained directly fromthem. When needed, consent will be obtained from a legal representative or from a personauthorized to consent on behalf of the resident. Resident assent will also be soughtverbally or behaviorally before participation. Before each visit, residents will be askedwhether they are still interested in participating. If a resident refuses, showsdistress, or no longer wishes to participate, study activities will stop.The purpose of this pilot trial is not to determine definitive effectiveness. Rather, itwill assess whether the intervention and study procedures are feasible, acceptable, andsafe for older adults with mild to moderate cognitive impairment or neurocognitivedisorder living in long‐term care settings.
Epistemonikos ID: 94bba58f0f8fb5783274b32b9dfc334806e29fe5
First added on: Jun 18, 2026