Virtual Reality Analgesia for Pediatric Burn Survivors

Not Applicable

Completed

• Conditions: Pain, Acute
• Interventions: Behavioral: virtual reality distraction (Yes VR); Behavioral: music distraction (No VR)

• Registration Number: NCT03491657
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study Start: 2014-03-13
• Primary Completion: 2017-01-03
• Study Completion: 2017-01-03
• Status Verified: 2018-03
• Study First Submitted: 2018-03-10
• Study First Submitted QC: 2018-03-31
• Study First Posted: 2018-04-09
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
virtual reality distraction (Yes VR)	virtual reality distraction (Yes VR)	In addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day.
music distraction (No VR condition)	music distraction (No VR)	In addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day.

Primary Outcome Measures

Name	Time	Method
"Worst Pain" rating of pain intensity during Music vs. during VR	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 Outcome Measures

Name	Time	Method
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	This single question measures the Cognitive component of pain during wound care. Patients will rate how much time they spent thinking about pain during burn wound care, on a zero to ten scale, where zero is "no time at all" and 10 is "the entire time". Lower scores represent better outcome. No subscales.
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	This single question measures positive affect during burn wound care. On a zero to ten scale, where zero is no fun at all and 10 is extremely fun. Higher scores represent better outcome. No subscales.
Child Health Questionnaire	measured at 0, 9 months and 12 month followup visits	Child Health Questionnaire The Child Health Questionnaire (CHQ) is a family of generic QOL instruments. The CHQ includes 87 scales that consider the effects of children's health on family functioning, and specific scales such as behavior and self-esteem. The CHQ measures 14 unique physical and psychosocial concepts. Questionnaires will be self-completed by the outpatients or parents, or both. Raw scores will converted to scaled scores from zero to 100. Higher scores indicate better health and better quality of life outcome.
Graphic Rating Scale Satisfaction with pain management during Music vs. during VR	Measured after wound care on Study Day 1.	This single question measures how satisfied the patient is with how well their pain was controlled during burn wound care. Higher scores represent better ourcomes. No subscales
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	This single question measures the emotional component of pain. On a scale from zero to ten, where zero is "not unpleasant at all", 10 is "excruciatingly unpleasant". Lower scores represent better outcome. No subscales.

Trial Locations

Locations (1)

Shriners Hospital for Children; Shriners Burns Hospital; 🇺🇸 Galveston, Texas, United States