Virtual Reality Analgesia for Pediatric Burn Survivors

The University of Texas System (UT)

Status: Completed

Conditions: Pain, Acute

Treatments: Behavioral: music distraction (No VR); Behavioral: virtual reality distraction (Yes VR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03491657

71011-GAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

virtual reality distraction (Yes VR)

Experimental group

Description:

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.

Treatment:

Behavioral: virtual reality distraction (Yes VR)

music distraction (No VR condition)

Active Comparator group

Description:

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.

Treatment:

Behavioral: music distraction (No VR)