Virtual Reality Distraction for Pediatric Burns

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pediatric BurnsVirtual Reality Distraction - Device
Eligibility
6 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether virtual reality can help burn patients during their painful wound-cleaning procedures.

Eligible Conditions
  • Pediatric Burns

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Immediately after the first sequence (T1); immediately after the second sequence (T2)

Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2)
Levels of anxiety
Pain
Pain intensity: Verbal Numerical Rating Scale (VNRS)
Immediately after the first sequence (T1); immediately after the second sequence (T2)
Mean difference in cognitive, affective and sensory components of pain between groups
Mean differences in maximal range-of-motion of injured limb(s)
Need for rescue medication
Occurrence of adverse events
Immediately after the second sequence (T2)
Children's satisfaction levels
Healthcare professional's satisfaction level
Parent's and children's satisfaction levels
One week after the procedure (T3)
Mean differences in children's memory of anxiety
Mean differences in children's memory of pain

Trial Safety

Trial Design

2 Treatment Groups

Standard Treatment
1 of 2
Virtual Reality Distraction
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Virtual Reality Distraction · No Placebo Group · N/A

Virtual Reality Distraction
Device
Experimental Group · 1 Intervention: Virtual Reality Distraction · Intervention Types: Device
Standard Treatment
Drug
ActiveComparator Group · 1 Intervention: Standard Treatment · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Distraction
2016
Completed Phase 3
~740

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after the first sequence (t1); immediately after the second sequence (t2)

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
179 Previous Clinical Trials
77,065 Total Patients Enrolled
Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital
8 Previous Clinical Trials
1,157 Total Patients Enrolled

Eligibility Criteria

Age 6 - 17 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
will be inpatient Between the ages of 6 to 17 years, if you have a burn injury that requires hydrotherapy, physiotherapy, or occupational therapy care, you will have to be hospitalized.
The child must have a consenting parent who can understand, read and write either French or English in order to be adopted from Quebec.