AR Vs VR in Burns Dressing Changes (AR vs VR)

December 3, 2024 updated by: Buckinghamshire Healthcare NHS Trust
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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

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

Accepts Healthy Volunteers

No

Description

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).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
This is standard care (what they would normally receive if they were not enrolled into this study)
Active Comparator: Participants randomised to wear AR headset
AR headset: MagicLeap 2 - running Divertini's "Watering Plants" world.
Device: 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.
Active Comparator: Participants randomised to wear VR headset
VR Headset: Oculus Quest 2 - Running SyncVR's Relaxation and Pain control simulations
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours

Collaborators and Investigators

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

Sponsor

Buckinghamshire Healthcare NHS Trust

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXQ 1136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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