NCT07447830

The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 Co-Primary Objectives: To preliminarily evaluate the effectiveness of iVR in reducing pain during wound care among LTC residents. To assess the feasibility and acceptability of implementing iVR for wound care in LTC from both resident and staff perspectives. Secondary Objective: To explore whether iVR use during wound care affects neuropsychiatric symptoms, specifically agitation and depression, using the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). Pain will be assessed using validated measures: the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II) and Pain Assessment in Advanced Dementia (PAINAD) for all participants, with the Numeric Pain Rating Scale (NPRS) used as an additional measure for cognitively apt residents capable of self-report. Methods This is a within-subject crossover study conducted at the Donald Berman Maimonides Geriatric Centre (Montreal, Quebec). Up to 20 residents receiving regular wound care for pressure ulcers will be recruited. Written informed consent will be obtained from participants or their legal representatives. Each participant will be followed for approximately six weeks, divided into three phases: Phase I - Baseline (2 weeks): Standard wound care without iVR. Phase II - Intervention (2 weeks): Wound care performed while the resident uses iVR. Phase III - Washout (2 weeks): Standard wound care resumed without iVR. Each resident serves as their own control, minimizing confounding and increasing statistical power. Pain will be measured at three time points per wound-care episode: One hour before the procedure, During the procedure, and One hour after the procedure. Pain will be assessed using PACSLAC-II and PAINAD for all residents, supplemented by NPRS scores when participants are able to self-report. Neuropsychiatric symptoms (agitation/aggression and depression/dysphoria) will be measured using the NPI-NH at two-week intervals and once post-intervention. Feasibility and Acceptability Evaluation Wound-care staff will complete brief questionnaires and/or interviews on usability, workflow integration, and perceived benefits or challenges. Observations will also document adherence and practicality in real-world LTC conditions. Study Design Overview Study Type: Interventional (within-subject crossover) Primary Purpose: Supportive care; feasibility and acceptability of iVR during wound care Study Phase: Not applicable (non-drug intervention) Allocation: Non-randomized Intervention Model: Within-subject crossover Masking: None (open-label) Setting: Donald Berman Maimonides Geriatric Centre, Montreal, Quebec Eligibility Criteria Inclusion Criteria: 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 Exclusion Criteria: 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 Expected Impact This pilot study will provide preliminary evidence on whether immersive virtual reality can reduce pain during wound care for older adults in LTC and whether it is feasible and acceptable for staff to implement. The study will also explore potential secondary benefits for mood and behavior. Findings will inform the design of a larger, multi-site trial examining clinical efficacy, implementation, and cost-effectiveness of iVR in Canadian LTC settings.

Conditions

• Wound Care
• Pain
• Neuropsychiatric Symptoms

Interventions

Type	Name	Description
DEVICE	Rendever Immersive Virtual Reality Platform	IVR headsets will provide calming, low-intensity scenes-like watching puppies in a meadow-to provide distraction and help reduce pain during wound care.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-12-01
• Completion: 2027-04-15
• First posted: 2026-03-04
• Last updated: 2026-03-05

Locations

2 sites across 1 country: Canada