Clinical trial NCT03491657: Virtual Reality Analgesia for Pediatric Burn Survivors
Official title: Virtual Reality Analgesia for Pediatric Burn Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: virtual reality pain
opioid
pediatric burn
wound care
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2018-04-09
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subject design with repeated measures, with random assignment to initial treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Compliant and able to complete subjective evaluations,
* A minimum of 10% of total burned surface area,
* No history of psychiatric (DSM-III-R Axis I) disorder(s),
* Not demonstrating delirium, psychosis or any form of organic brain disorder,
* Able to communicate verbally in English or Spanish,
* Admitted to UTMB/Shriners, 6-17 years of age.

Exclusion criteria:

* No wound cleaning sessions required.
* Less than 10% of total burned surface area.
* History of psychiatric (DSM-III-R Axis I) disorder(s).
* Demonstrating delirium, psychosis or organic brain disorder.
* Unable to communicate verbally in English or Spanish.
* History of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment.
* Receiving prophylaxis for alcohol or drug withdrawal,
* Developmental disability, Younger than 6 years; older than 17 years,
* Burns of eyes, eyelids or face so severe they preclude the use of VR,
* Worst pain intensity of less than 5 on a 0 to 10 scale, during baseline No VR wound care Day 1.

Primary outcomes:
measure: "Worst Pain" rating of pain intensity during Music vs. during VR
timeFrame: measured after burn wound care on each study day for up to 10 study days per patient
Secondary outcomes:
measure: Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR
timeFrame: measured after burn wound care on each study day for up to 10 study days per patient
measure: Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR
timeFrame: measured after woundcare on each study day for up to 10 study days per patient
measure: Graphic Rating Scale "Fun" during Music vs. during VR
timeFrame: measured after wound care on each study day for up to 10 study days per patient
measure: Graphic Rating Scale Satisfaction with pain management during Music vs. during VR
timeFrame: Measured after wound care on Study Day 1.
measure: Child Health Questionnaire
timeFrame: measured at 0, 9 months and 12 month followup visits
Other outcomes:
measure: Sullivans Pain Catastrophizing Scale for Children (Crombez et al., 2003).
timeFrame: measured on Study day 1
Locations:
city: Galveston
country: United States
facility: Shriners Hospital for Children; Shriners Burns Hospital
state: Texas
Study officials:
affiliation: UTMB/Shriners
name: Walter J Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.
citation: Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.