Burns MultipleAR vs VRNCT06721780
AR Vs VR in Burns Dressing Changes
A study testing Participants randomised to wear AR headset and Participants randomised to wear VR headset in people with Burns Multiple, run by Buckinghamshire Healthcare NHS Trust.
Trial summary
For children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. This process is not only distressing for the children but also for their parents and the healthcare professionals involved. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Burns Multiple
- What is being tested?
- Participants randomised to wear AR headset and Participants randomised to wear VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Feb 2026
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Participants presenting with guardians with parental responsibility, who are willing and able to consent to recruitment.
- Aged 4-17 years
- Presenting with burns requiring a dressing change, on their first attendance to the burns clinic.
- Participating child is able to complete the FACES Pain Scale
Who cannot join
- • Children aged 4 or below
- Those with severe cognitive impairment, visual disorders, facial burns or other conditions preventing the safe use of VR/AR technology.
- Previous 'cybersickness' symptoms (nausea, dizziness).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
For children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. This process is not only distressing for the children but also for their parents and the healthcare professionals involved. Current methods to reduce this trauma include the use of play therapists, but such resources are often limited. There is good evidence that Augmented Reality (AR) and Virtual Reality (VR) can help by providing a distracting and immersive environment that eases pain and fear. However, no studies have yet compared these two modern technologies to see which is more effective
- Conditions
- Burns Multiple
- Being tested
- Participants randomised to wear AR headset, Participants randomised to wear VR headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants randomised to wear AR headsetDevice
Participants will use an AR headset that employs a distraction game specifically designed for children and young adults undergoing painful procedures.
Participants randomised to wear VR headsetDevice
Participants will utilise a VR headset, running a calming virtual environment or an interactive game during the dressing change.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | This is standard care (what they would normally receive if they were not enrolled into this study) |
| Participants randomised to wear AR headset | Active comparator | AR headset: MagicLeap 2 - running Divertini's "Watering Plants" world. Receives: Device: Participants randomised to wear AR headset |
| Participants randomised to wear VR headset | Active comparator | VR Headset: Oculus Quest 2 - Running SyncVR's Relaxation and Pain control simulations Receives: Device: Participants randomised to wear VR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the relative performance
To determine the relative performance of AR and VR in pain and anxiety control during burns dressings changes in comparison to standard of care.
Objective measures: Pulse rate, Respiratory rate
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startFeb 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns MultipleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721780
- Sponsor's protocol ID
- RXQ 1136
- Acronym
- AR vs VR
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AR Vs VR in Burns Dressing Changes
- ClinicalTrials.gov ID
- NCT06721780
- Acronym / sponsor ID
- AR vs VR / RXQ 1136
- Conditions
- Burns Multiple
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
For children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. This process is not only distressing for the children but also for their parents and the healthcare professionals involved. Current methods to reduce this trauma include the use of play therapists, but such resources are often limited. There is good evidence that Augmented Reality (AR) and Virtual Reality (VR) can help by providing a distracting and immersive environment that eases pain and fear. However, no studies have yet compared these two modern technologies to see which is more effective
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –This is standard care (what they would normally receive if they were not enrolled into this study) |
| Participants randomised to wear AR headset | Active comparator | Device: Participants randomised to wear AR headsetAR headset: MagicLeap 2 - running Divertini's "Watering Plants" world. |
| Participants randomised to wear VR headset | Active comparator | Device: Participants randomised to wear VR headsetVR Headset: Oculus Quest 2 - Running SyncVR's Relaxation and Pain control simulations |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Participants presenting with guardians with parental responsibility, who are willing and able to consent to recruitment.
Key exclusion criteria (3 listed)
- • Children aged 4 or below
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 |
|---|---|---|
| Participants randomised to wear AR headsetParticipants will use an AR headset that employs a distraction game specifically designed for children and young adults undergoing painful procedures. | Device | Participants randomised to wear AR headset |
| Participants randomised to wear VR headsetParticipants will utilise a VR headset, running a calming virtual environment or an interactive game during the dressing change. | Device | Participants randomised to wear VR headset |
Primary outcome
determine the relative performance
Time frame: 2 hours
To determine the relative performance of AR and VR in pain and anxiety control during burns dressings changes in comparison to standard of care. Objective measures: Pulse rate, Respiratory rate
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 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Participants randomised to wear AR headset and Participants randomised to wear VR headset in people with Burns Multiple, run by Buckinghamshire Healthcare NHS Trust.
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 3 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Akshat Sawhney, MBBS BSc MRCS (01296 831378, bht.research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the relative performance (time frame: 2 hours). 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 6 Dec 2024.