NCT03155607

Novel Virtual Reality for Burn Wound Care Pain in Adolescents

Completed NA Last updated 12 January 2022

What this trial tests

NA trial testing Virtual Reality Distraction in Burns in 43 participants. Completed in 2 December 2021.

Timeline

4 January 2018

Primary endpoint
2 December 2021

2 December 2021

Quick facts

Lead sponsor	University of Arkansas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	43
Start date	4 January 2018
Primary completion	2 December 2021
Estimated completion	2 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Virtual Reality Distraction

Conditions studied

• Burns — all drugs for Burns →

Sponsor

University of Arkansas

Who can join

Adults 10 to 21, any sex, with Burns. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Virtual reality distraction for acute pain in children.
   Lambert V, Boylan P, Boran L, Hicks P, et al · · 2020 · cited 50× · PMID 33089901 · DOI 10.1002/14651858.cd010686.pub2