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Novel Virtual Reality for Burn Wound Care Pain in Adolescents

NCT03155607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-01-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

Virtual Reality Distraction

Patient will utilize a virtual reality device during wound care.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Debra Jeffs, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03155607 on ClinicalTrials.gov