Clinical trial NCT03155607: Novel Virtual Reality for Burn Wound Care Pain in Adolescents
Official title: Novel Virtual Reality for Burn Wound Care Pain in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain perception during burn wound care of first clinic visit
timeFrame: From study consent, data collection, and randomization at beginning of clinic visit until final data collection at discharge from clinic; approximately 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Debra Jeffs, PhD
role: PRINCIPAL_INVESTIGATOR
References: