Immersive Virtual Reality for Older Adults in Long-Term Care Settings (VR-LTC)

June 16, 2026 updated by: Martine Bordeleau, Laval University

Use of Immersive Virtual Reality in Long-Term Care Facilities and Seniors' Homes in Quebec

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot feasibility trial will evaluate the use of a mindfulness meditation intervention delivered with or without the Toujours Dimanche immersive virtual reality application in long-term care settings in Quebec. The study will be conducted with older adults living in long-term care facilities, seniors' homes, and alternative seniors' homes in the Chaudière-Appalaches and Capitale-Nationale regions who have mild to moderate cognitive impairment or neurocognitive disorder.

The pilot phase will use a randomized experimental design. The purpose of this phase is to evaluate the feasibility, acceptability, safety, user experience, and preliminary effects of the intervention in real-world long-term care settings. This phase will also help identify practical issues related to time management, human resources, data collection, and intervention delivery before a future larger-scale effectiveness trial.

A total of 36 residents will be recruited. This sample size is based on recommendations for feasibility studies, with 12 participants per group. Staff members who regularly work with participating residents and who have completed virtual reality training through Super Splendide and/or Martine Bordeleau will also be recruited. These staff members will deliver the intervention and provide feedback on its feasibility and acceptability.

Residents who meet the inclusion and exclusion criteria will be assigned to one of three groups. Group A will receive standard care and guided mindfulness meditation sessions designed for people with cognitive impairment. Group B will receive standard care and the adapted version of the Toujours Dimanche program, which includes guided mindfulness meditation sessions designed for people with cognitive impairment. Group C will receive standard care for four weeks.

Allocation to the groups will be performed using minimization, a method recognized as an acceptable alternative to randomization when the sample size is small. The allocation procedure will consider sex, gender, and age group. The study coordinator will have access to participants' group allocation. The long-term care team will plan the intervention 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 meditation sessions over 4 consecutive weeks, with approximately 2 sessions per week. Each session will last about 5 to 15 minutes, depending on the participant's preferences, comfort, and tolerance. The sessions will be delivered by trained staff members who know the participating 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 has difficulty communicating verbally or through gestures, the staff member who knows the resident best may provide responses using observer-rated versions of the questionnaires. Sociodemographic information will be collected at baseline. Feedback on the program will be collected after the 4-week study period from residents, when possible, and from staff members.

Feasibility outcomes will include recruitment, adherence, attrition, intervention completion, and practical challenges encountered during implementation. Acceptability will be assessed from the perspectives of residents and staff using researcher-developed questions, including visual analogue scales and open-ended questions. User experience, perceived presence, potential risks, side effects, and other practical issues will also be documented.

Preliminary clinical outcomes will be assessed before the beginning of the intervention and after the end of the 4-week period. The primary clinical outcomes are depression and anxiety. Quality of life will be assessed as a secondary outcome. Mindfulness, pain, and loneliness will be assessed as tertiary or exploratory outcomes. Measures will be administered in a predefined order, beginning with depression and anxiety, followed by quality of life, and then the exploratory outcomes. If a participant shows signs of excessive fatigue or reduced motivation, data collection may be paused or stopped.

Because the study includes residents with cognitive impairment, consent and assent procedures will be adapted to protect residents' rights, comfort, and dignity. When residents are able to provide informed consent, consent will be obtained directly from them. When needed, consent will be obtained from a legal representative or from a person authorized to consent on behalf of the resident. Resident assent will also be sought verbally or behaviorally before participation. Before each visit, residents will be asked whether they are still interested in participating. If a resident refuses, shows distress, or no longer wishes to participate, study activities will stop.

The purpose of this pilot trial is not to determine definitive effectiveness. Rather, it will assess whether the intervention and study procedures are feasible, acceptable, and safe for older adults with mild to moderate cognitive impairment or neurocognitive disorder living in long-term care settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Guided Mindfulness Meditation
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
Mindfulness Meditation for Cognitive Impairment
Other: Usual Care
Standard Care
Experimental: Adapted Toujours Dimanche Virtual Reality Meditation
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.
Other: Usual Care
Standard Care
Device: Adapted Virtual Reality Mindfulness Meditation Program
Immersive Virtual Reality Mindfulness Meditation
Active Comparator: Standard Care
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
Standard Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment, Retention, Adherence, Blinding, and Safety Feasibility Indicators
Time Frame: 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.
Up to 4 weeks
Acceptability of the Intervention
Time Frame: 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.
At 4 weeks
Change in Depression Symptoms
Time Frame: 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.
Baseline and 4 weeks
Change in Anxiety Symptoms
Time Frame: 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
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-Reported Pain Intensity
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Change in Observed Pain
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Change in Loneliness
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Change in Social Engagement
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks
Change in Daily Mindful Responding
Time Frame: Baseline and 4 weeks
Daily mindful responding will be assessed using the Daily Mindful Responding Scale (DMRS), completed by the resident when possible. The DMRS is a 4-item scale designed to assess mindful responding in daily life. Items are rated on a 1-to-10 scale, and item scores are averaged to compute the total score. Total scores range from 1 to 10. Higher scores indicate greater mindful responding in daily life.
Baseline and 4 weeks
Change in Observed Mindfulness
Time Frame: Baseline and 4 weeks
Observed mindfulness will be assessed using the Observed Mindfulness Measure (OMM), completed by a staff member who knows the resident. The OMM is a 9-item observer-rated questionnaire assessing mindful behaviors, including awareness, acceptance, and attentiveness. Total scores range from 9 to 45. Higher scores indicate greater observed mindful behavior.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McGill University
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maude Laberge, PhD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-23-2024-1086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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