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Novel Virtual Reality for Burn Wound Care Pain in Adolescents

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Distraction
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Virtual Reality Distraction

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2017
Last Updated
January 11, 2022
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03155607
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Virtual Reality Distraction
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Distraction
Intervention Description
Patient will utilize a virtual reality device during wound care.
Primary Outcome Measure Information:
Title
Pain perception during burn wound care of first clinic visit
Description
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
Time Frame
From study consent, data collection, and randomization at beginning of clinic visit until final data collection at discharge from clinic; approximately 2 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Jeffs, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Virtual Reality for Burn Wound Care Pain in Adolescents

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