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AR Vs VR in Burns Dressing Changes

NCT ID: NCT06721780

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Burns Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

This is standard care (what they would normally receive if they were not enrolled into this study)

Group Type NO_INTERVENTION

No interventions assigned to this group

Participants randomised to wear AR headset

AR headset: MagicLeap 2 - running Divertini's "Watering Plants" world.

Group Type ACTIVE_COMPARATOR

Participants randomised to wear AR headset

Intervention Type DEVICE

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 headset

VR Headset: Oculus Quest 2 - Running SyncVR's Relaxation and Pain control simulations

Group Type ACTIVE_COMPARATOR

Participants randomised to wear VR headset

Intervention Type DEVICE

Participants will utilise a VR headset, running a calming virtual environment or an interactive game during the dressing change.

Interventions

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Participants randomised to wear AR headset

Participants will use an AR headset that employs a distraction game specifically designed for children and young adults undergoing painful procedures.

Intervention Type DEVICE

Participants randomised to wear VR headset

Participants will utilise a VR headset, running a calming virtual environment or an interactive game during the dressing change.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • 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

Exclusion Criteria

* • 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).
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Akshat Sawhney, MBBS BSc MRCS

Role: CONTACT

Phone: 01296 831378

Email: [email protected]

James Cooper, BSc, MSc

Role: CONTACT

Phone: 07816020305

Email: [email protected]

Other Identifiers

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RXQ 1136

Identifier Type: -

Identifier Source: org_study_id