Wound CarePRISMNCT07447830
The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study
A study testing Rendever Immersive Virtual Reality Platform in people with Wound Care and Pain, run by McGill University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Care, Pain, Neuropsychiatric Symptoms
- What is being tested?
- Rendever Immersive Virtual Reality Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Donald Berman Maimonides Maimonides Geriatric Centre
Montreal, Quebec, H4W 1W3
Ava ter Horst, BSc, (514) 483-2121 ext. 71801, ava.terhorst.ccomtl@ssss.gouv.qc.ca
Stephanie A Ballard, MSc, 5144832121 ext. 72386, stephanie.ballard@mail.mcgill.ca
- Recruiting
Donald Berman Maimonides Maimonides Geriatric Centre
Montreal, Quebec, H4W 1W3
Dr. Machelle Wilchesky, PhD, 514-340-8222 ext. 28391, machelle.wilchesky@mcgill.ca
Stephanie A Ballard, MSc, 514-340-8222 ext. 23176, stephanie.ballard@mail.mcgill.ca
About this study
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.
Read more
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.
Read the 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
- Being tested
- Rendever Immersive Virtual Reality Platform
- Keywords
- immersive virtual reality, pain, wound care, depression, aggitation
- Medical subject headings
- Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rendever Immersive Virtual Reality PlatformDevice
IVR headsets will provide calming, low-intensity scenes-like watching puppies in a meadow-to provide distraction and help reduce pain during wound care.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality during wound care | Experimental | Immersive virtual reality will be used during wound care procedures Receives: Device: Rendever Immersive Virtual Reality Platform |
| Usual Care | No intervention | No immersive reality use during wound care procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II)
Pain assessment tool
Measured: 6 weeks
Pain Assessment in Advanced Dementia (PAINAD)
Pain assessment tool
Measured: 6 weeks
Secondary outcomes (1)
Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Neuropsychiatric symptom assessment tool
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Lady Davis Institute
- Responsible party
- Principal investigator, Machelle Wilchesky, McGill University
- Investigators
- Machelle Wilchesky, PhD, Principal investigator, Lady Davis Institute-CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447830
- Sponsor's protocol ID
- #2025-4494
- Acronym
- PRISM
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study
- ClinicalTrials.gov ID
- NCT07447830
- Acronym / sponsor ID
- PRISM / #2025-4494
- Conditions
- Wound Care, Pain, Neuropsychiatric Symptoms
- Keywords
- immersive virtual reality, pain, wound care, depression, aggitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Lady Davis Institute
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality during wound care | Experimental | Device: Rendever Immersive Virtual Reality PlatformImmersive virtual reality will be used during wound care procedures |
| Usual Care | No intervention | –No immersive reality use during wound care procedures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rendever Immersive Virtual Reality PlatformIVR headsets will provide calming, low-intensity scenes-like watching puppies in a meadow-to provide distraction and help reduce pain during wound care. | Device | Immersive virtual reality during wound care |
Primary outcome
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II)
Time frame: 6 weeks
Pain assessment tool
Pain Assessment in Advanced Dementia (PAINAD)
Time frame: 6 weeks
Pain assessment tool
1 secondary outcome
Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Machelle Wilchesky, PhD principal investigator
Lady Davis Institute-CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rendever Immersive Virtual Reality Platform in people with Wound Care and Pain, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Machelle Wilchesky, PhD ((514) 340-8222 ext. 28391, machelle.wilchesky@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC-II) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.