Use of Immersive Virtual Reality in Long-Term Care Facilities and Seniors' Homes in Quebec
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
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
详细描述
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 24 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 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 two groups. Group A 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 B 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking will be used. Participants, care providers, investigators, and outcome assessors may be aware of group assignment because the intervention involves visible virtual reality equipment and is delivered in real-world long-term care settings.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •For resident participants:
- •Recurrent migraines
- •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
研究组 & 干预措施
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.
干预措施: Adapted Virtual Reality Mindfulness Meditation Program (Device)
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.
干预措施: Usual Care (Other)
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.
干预措施: Usual Care (Other)
研究者
Martine Bordeleau
Principal Investigator
Laval University