The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II)
研究概览
简要总结
This study will test whether immersive virtual reality (iVR) can reduce pain and discomfort during wound care for residents living in long-term care (LTC). Pressure ulcers are common and painful among older adults, and dressing changes often cause additional distress.
Up to 20 residents at the Donald Berman Maimonides Geriatric Centre will use virtual reality headsets during routine wound care. The headsets display calm, low-stimulus scenes (e.g., puppies in a meadow) designed to distract and comfort participants.
Each participant will take part for six weeks in three phases:
- Two weeks of usual wound care (baseline)
- Two weeks using virtual reality during wound care (intervention)
- Two weeks of usual care again (washout)
Pain will be assessed using validated tools, and the research team will also observe agitation, mood, and other behavioral indicators. Nursing staff will provide feedback on feasibility and acceptability of iVR use in LTC settings.
详细描述
Pressure ulcers (PUs), also known as pressure injuries, are localized wounds to the skin and underlying tissue caused by prolonged pressure, often in combination with shear and friction. They are a painful and frequent complication in long-term care (LTC), associated with reduced quality of life and increased morbidity and mortality. Despite this, there is limited evidence on effective strategies to reduce pain during wound care procedures in this population.
Immersive Virtual Reality (iVR) has shown promise as a non-pharmacological approach to pain management through distraction and sensory engagement. Studies in other clinical contexts suggest that iVR can reduce perceived pain intensity during procedures, but evidence in older adults living in LTC-particularly during wound care for pressure ulcers-is scarce.
In residents with dementia, pain can also worsen neuropsychiatric symptoms (NPS) such as agitation and mood disturbances, further complicating care. This highlights the importance of testing interventions that not only reduce pain but may also improve overall comfort and behavioral well-being.
The PRISM study (Pain Reduction through Immersive Simulation in Maimonides) was designed to address these gaps.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of LTC for ≥2 weeks
- •Receiving regular wound care for pressure ulcers
- •Able to tolerate iVR headset use
- •(If cognitively apt) able to understand English or French
排除标准
- •Blindness, severe cataracts, or glaucoma
- •Allergies to synthetic plastics or headset materials
- •Head or ear wounds preventing headset placement
- •Peripheral neuropathy
- •Dangerous or aggressive behaviors in the past 30 days
研究组 & 干预措施
Immersive virtual reality during wound care
Immersive virtual reality will be used during wound care procedures
干预措施: Rendever Immersive Virtual Reality Platform (Device)
Usual Care
No immersive reality use during wound care procedures
结局指标
主要结局
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II)
时间窗: 6 weeks
Pain assessment tool
Pain Assessment in Advanced Dementia (PAINAD)
时间窗: 6 weeks
Pain assessment tool
次要结局
- Neuropsychiatric Inventory Nursing Home Version (NPI-NH)(6 weeks)
研究者
Machelle Wilchesky
Associate Professor
McGill University