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Novel Virtual Reality for Burn Wound Care Pain in Adolescents

University of Arkansas logo

University of Arkansas

Status

Completed

Conditions

Burns

Treatments

Behavioral: Virtual Reality Distraction

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Burn wounds cause intense, complex pain, and subsequent burn wound care causes further intense, episodic pain that is often unrelieved by opioid and non-opioid medications, resulting in under-treatment of pain. Further, opioid analgesics can have untoward side effects including respiratory depression, nausea, constipation, pruritus, drowsiness, lethargy, dependence, and induced hyperalgesia. As one of the most severe types of pain, burn wound care pain adds to the trauma pediatric patients already experience from the burn itself impacting quality of life with subsequent behavioral and maladaptive responses, such as agitation, anger, anxiety, hyperactivity, uncooperativeness, aggression, and dissociation. Lack of control over the procedure, pain memory, anxiety in anticipation of the repeated painful nature of the procedure, and transmission of clinician distress associated with inflicting procedural pain on the child contribute to the pain perceived.

Virtual reality (VR) shows great promise as an engaging, interactive, effective non-pharmacologic intervention for various painful healthcare procedures, including burn wound care, therapies, and chronic pain conditions, despite equivocal findings, perhaps due to methodological issues. Designs of many studies of VR during burn wound care have been case studies or carefully controlled within-subject designs; sample sizes have been small. Recommendations for ongoing research include conducting more rigorous studies including randomized controlled trials (RCTs), repeat design studies, testing VR throughout the healthcare procedure, comparing VR to other distraction interventions; and using larger sample sizes.

Primary Aim 1: Compare the effectiveness of age-appropriate, consumer available, high technology, interactive VR with standard care (SC) on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory outpatient clinic setting.

Enrollment

43 patients

Sex

All

Ages

10 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergoing burn wound care
  • First visit to the outpatient Arkansas Children's Hospital (ACH) Burn Clinic or first wound care procedure in the Burn Clinic without sedation
  • Ages 10 through 21 years (based on a developmental framework of early adolescence: 10-13 years, middle-adolescence: 14-17 years, and late adolescence: 18-21 years)
  • English speaking (Note: Not all data collection tools are available in languages other than English)

Exclusion criteria

  • Any wounds that may interfere with study procedures (Previously, we did not have to exclude facial, head, neck or hand burns but were able to adapt the VR equipment.)
  • History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
  • Incarcerated minors
  • Minors in foster care
  • Presence of a cognitive developmental disability determined on prescreening by presence of a Section 504 accommodation plan or Title VIII individualized educational plan (IEP) in school. If IEP or 504 plan is unrelated to a cognitive delay, then the adolescent will be included in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

Standard Care
No Intervention group
Virtual Reality Distraction
Experimental group
Treatment:
Behavioral: Virtual Reality Distraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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