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Recruiting NCT07447830

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

No phase Interventional Wound Care Pain Neuropsychiatric Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rendever Immersive Virtual Reality Platform.
Who it may be relevant to
Registry conditions: Wound Care, Pain, Neuropsychiatric Symptoms. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II) [Time frame: 6 weeks]
  • Pain Assessment in Advanced Dementia (PAINAD) [Time frame: 6 weeks]
Secondary outcome measures (1)
  • Neuropsychiatric Inventory Nursing Home Version (NPI-NH) [Time frame: 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 2 centers
  • Donald Berman Maimonides Maimonides Geriatric Centre — Montreal
  • Donald Berman Maimonides Maimonides Geriatric Centre — Montreal

Identifiers

NCT: NCT07447830 · #2025-4494

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗