NCT06721780

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

November 26, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 hours

Study Arms (3)

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.

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

Device: Participants randomised to wear VR headset

Interventions

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 AR headset

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

Participants randomised to wear VR headset

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Akshat Sawhney, MBBS BSc MRCS

CONTACT

James Cooper, BSc, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 6, 2024

Study Start

February 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share