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Clinical Trials/NCT03491657
NCT03491657
Completed
Not Applicable

Virtual Reality Analgesia for Pediatric Burn Survivors

The University of Texas Medical Branch, Galveston1 site in 1 country62 target enrollmentMarch 13, 2014
ConditionsPain, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
62
Locations
1
Primary Endpoint
"Worst Pain" rating of pain intensity during Music vs. during VR
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

Detailed Description

All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.

Registry
clinicaltrials.gov
Start Date
March 13, 2014
End Date
January 3, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

"Worst Pain" rating of pain intensity during Music vs. during VR

Time Frame: measured after burn wound care on each study day for up to 10 study days per patient

worst pain during wound care. This single question measures the sensory component of pain during wound care. Patients will rate their "worst pain" during burn wound care. on a zero to ten scale, where zero is "no pain at all " and 10 is "excruciating pain". Lower scores represent better outcome. No subscales.

Secondary Outcomes

  • Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR(measured after burn wound care on each study day for up to 10 study days per patient)
  • Graphic Rating Scale "Fun" during Music vs. during VR(measured after wound care on each study day for up to 10 study days per patient)
  • Child Health Questionnaire(measured at 0, 9 months and 12 month followup visits)
  • Graphic Rating Scale Satisfaction with pain management during Music vs. during VR(Measured after wound care on Study Day 1.)
  • Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR(measured after woundcare on each study day for up to 10 study days per patient)

Study Sites (1)

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