Novel Virtual Reality for Burn Wound Care Pain in Adolescents

Burns Clinical Trial

Official title:

Novel Virtual Reality for Burn Wound Care Pain in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155607
• Other study ID #: 206406
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: December 2, 2021

Study information

• Verified date: January 2022
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Behavioral:
• Virtual Reality Distraction
Patient will utilize a virtual reality device during wound care.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.