Virtual Reality Analgesia for Pediatric Burn Survivors

NCT03491657 | Completed

• 1 other identifier: 71011-GAL
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

Conditions

Pain, Acute

Keywords

virtual reality pain; opioid; pediatric burn; wound care

Outcome Measures

Primary Outcomes (1)

• "Worst Pain" rating of pain intensity during Music vs. during VR

  worst pain during wound care. This single question measures the sensory component of pain during wound care. Patients will rate their "worst pain" during burn wound care. on a zero to ten scale, where zero is "no pain at all " and 10 is "excruciating pain". Lower scores represent better outcome. No subscales.

  measured after burn wound care on each study day for up to 10 study days per patient

Secondary Outcomes (5)

• Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR

  measured after burn wound care on each study day for up to 10 study days per patient

• Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR

  measured after woundcare on each study day for up to 10 study days per patient

• Graphic Rating Scale "Fun" during Music vs. during VR

  measured after wound care on each study day for up to 10 study days per patient

• Graphic Rating Scale Satisfaction with pain management during Music vs. during VR

  Measured after wound care on Study Day 1.

• Child Health Questionnaire

  measured at 0, 9 months and 12 month followup visits

Other Outcomes (1)

• Sullivans Pain Catastrophizing Scale for Children (Crombez et al., 2003).

  measured on Study day 1

Study Arms (2)

virtual reality distraction (Yes VR)

EXPERIMENTAL

In addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day.

Behavioral: virtual reality distraction (Yes VR)

music distraction (No VR condition)

ACTIVE COMPARATOR

In addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day.

Behavioral: music distraction (No VR)

Interventions

virtual reality distraction (Yes VR) BEHAVIORAL

virtual reality distraction (Yes VR)

music distraction (No VR) BEHAVIORAL

music distraction (No VR condition)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Compliant and able to complete subjective evaluations,
• A minimum of 10% of total burned surface area,
• No history of psychiatric (DSM-III-R Axis I) disorder(s),
• Not demonstrating delirium, psychosis or any form of organic brain disorder,
• Able to communicate verbally in English or Spanish,
• Admitted to UTMB/Shriners, 6-17 years of age.

You may not qualify if:

• No wound cleaning sessions required.
• Less than 10% of total burned surface area.
• History of psychiatric (DSM-III-R Axis I) disorder(s).
• Demonstrating delirium, psychosis or organic brain disorder.
• Unable to communicate verbally in English or Spanish.
• History of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment.
• Receiving prophylaxis for alcohol or drug withdrawal,
• Developmental disability, Younger than 6 years; older than 17 years,
• Burns of eyes, eyelids or face so severe they preclude the use of VR,
• Worst pain intensity of less than 5 on a 0 to 10 scale, during baseline No VR wound care Day 1.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Hospital for Children; Shriners Burns Hospital

Galveston, Texas, 77550, United States

Location

Related Publications (2)

• Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.

  PMID: 21264690 BACKGROUND

• Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.

  PMID: 12927636 BACKGROUND

Related Links

• www.vrpain.com

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Walter J Meyer, MD

  UTMB/Shriners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding can be challenging in behavioral studies. To help control for demand characteristics, the current study uses an active comparator "music distraction" vs. the experimental treatment condition "immersive virtual reality".
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject design with repeated measures, with random assignment to initial treatment.

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: April 9, 2018
• Study Start: March 13, 2014
• Primary Completion: January 3, 2017
• Study Completion: January 3, 2017
• Last Updated: July 11, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)