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

March 3, 2026 updated by: Machelle Wilchesky, McGill University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4W 1W3
      • Montreal, Quebec, Canada, H4W 1W3
        • Recruiting
        • Donald Berman Maimonides Maimonides Geriatric Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Machelle Wilchesky, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immersive virtual reality during wound care
Immersive virtual reality will be used during wound care procedures
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.
No Intervention: Usual Care
No immersive reality use during wound care procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II)
Time Frame: 6 weeks
Pain assessment tool
6 weeks
Pain Assessment in Advanced Dementia (PAINAD)
Time Frame: 6 weeks
Pain assessment tool
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Time Frame: 6 weeks
Neuropsychiatric symptom assessment tool
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Lady Davis Institute

Investigators

  • Principal Investigator: Machelle Wilchesky, PhD, Lady Davis Institute-CIUSSS du Centre-Ouest-de-l'Île-de-Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2025-4494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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