Novel Virtual Reality for Burn Wound Care Pain in Adolescents

NCT03155607 | Completed

• 1 other identifier: 206406
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Pain perception during burn wound care of first clinic visit

  Pain perception as described by utilizing the Adolescent Pediatric Pain Tool. Pain is based on a 0 (No pain) to 10 (maximum pain) sonometer scale as told by patient

  From study consent, data collection, and randomization at beginning of clinic visit until final data collection at discharge from clinic; approximately 2 hours.

Study Arms (2)

Standard Care

NO INTERVENTION

Virtual Reality Distraction

EXPERIMENTAL

Behavioral: Virtual Reality Distraction

Interventions

Virtual Reality Distraction BEHAVIORAL

Patient will utilize a virtual reality device during wound care.

Virtual Reality Distraction

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Debra Jeffs, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: January 4, 2018
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)