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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Shriners Hospital for Children; Shriners Burns Hospital
Galveston, Texas, United States
"Worst Pain" rating of pain intensity during Music vs. during VR
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.
Time frame: measured after burn wound care on each study day for up to 10 study days per patient
Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR
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.
Time frame: measured after burn wound care on each study day for up to 10 study days per patient
Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR
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.
Time frame: measured after woundcare on each study day for up to 10 study days per patient
Graphic Rating Scale "Fun" during Music vs. during VR
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.
Time frame: measured after wound care on each study day for up to 10 study days per patient
Graphic Rating Scale Satisfaction with pain management during Music vs. during VR
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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
Time frame: Measured after wound care on Study Day 1.
Child Health Questionnaire
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.
Time frame: measured at 0, 9 months and 12 month followup visits