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

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

• Neuropsychiatric Inventory Nursing Home Version (NPI-NH) [Срок оценки: 6 weeks]