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Virtual Reality Analgesia for Pediatric Burn Survivors

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual reality distraction (Yes VR)
music distraction (No VR)
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring virtual reality pain, opioid, pediatric burn, wound care

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Sites / Locations

  • Shriners Hospital for Children; Shriners Burns Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

virtual reality distraction (Yes VR)

music distraction (No VR condition)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

"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.

Secondary Outcome Measures

Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR
This single question measures the Cognitive component of pain during wound care. Patients will rate how much time they spent thinking about pain during burn wound care, on a zero to ten scale, where zero is "no time at all" and 10 is "the entire time". Lower scores represent better outcome. No subscales.
Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR
This single question measures the emotional component of pain. On a scale from zero to ten, where zero is "not unpleasant at all", 10 is "excruciatingly unpleasant". Lower scores represent better outcome. No subscales.
Graphic Rating Scale "Fun" during Music vs. during VR
This single question measures positive affect during burn wound care. On a zero to ten scale, where zero is no fun at all and 10 is extremely fun. Higher scores represent better outcome. No subscales.
Graphic Rating Scale Satisfaction with pain management during Music vs. during VR
This single question measures how satisfied the patient is with how well their pain was controlled during burn wound care. Higher scores represent better ourcomes. No subscales
Child Health Questionnaire
Child Health Questionnaire The Child Health Questionnaire (CHQ) is a family of generic QOL instruments. The CHQ includes 87 scales that consider the effects of children's health on family functioning, and specific scales such as behavior and self-esteem. The CHQ measures 14 unique physical and psychosocial concepts. Questionnaires will be self-completed by the outpatients or parents, or both. Raw scores will converted to scaled scores from zero to 100. Higher scores indicate better health and better quality of life outcome.

Full Information

First Posted
March 10, 2018
Last Updated
July 9, 2018
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT03491657
Brief Title
Virtual Reality Analgesia for Pediatric Burn Survivors
Official Title
Virtual Reality Analgesia for Pediatric Burn Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 13, 2014 (Actual)
Primary Completion Date
January 3, 2017 (Actual)
Study Completion Date
January 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Shriners Hospitals for Children

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
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.
Detailed Description
All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
virtual reality pain, opioid, pediatric burn, wound care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within-subject design with repeated measures, with random assignment to initial treatment.
Masking
None (Open Label)
Masking Description
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".
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality distraction (Yes VR)
Arm Type
Experimental
Arm Description
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.
Arm Title
music distraction (No VR condition)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
virtual reality distraction (Yes VR)
Intervention Type
Behavioral
Intervention Name(s)
music distraction (No VR)
Primary Outcome Measure Information:
Title
"Worst Pain" rating of pain intensity during Music vs. during VR
Description
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.
Time Frame
measured after burn wound care on each study day for up to 10 study days per patient
Secondary Outcome Measure Information:
Title
Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR
Description
This single question measures the Cognitive component of pain during wound care. Patients will rate how much time they spent thinking about pain during burn wound care, on a zero to ten scale, where zero is "no time at all" and 10 is "the entire time". Lower scores represent better outcome. No subscales.
Time Frame
measured after burn wound care on each study day for up to 10 study days per patient
Title
Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR
Description
This single question measures the emotional component of pain. On a scale from zero to ten, where zero is "not unpleasant at all", 10 is "excruciatingly unpleasant". Lower scores represent better outcome. No subscales.
Time Frame
measured after woundcare on each study day for up to 10 study days per patient
Title
Graphic Rating Scale "Fun" during Music vs. during VR
Description
This single question measures positive affect during burn wound care. On a zero to ten scale, where zero is no fun at all and 10 is extremely fun. Higher scores represent better outcome. No subscales.
Time Frame
measured after wound care on each study day for up to 10 study days per patient
Title
Graphic Rating Scale Satisfaction with pain management during Music vs. during VR
Description
This single question measures how satisfied the patient is with how well their pain was controlled during burn wound care. Higher scores represent better ourcomes. No subscales
Time Frame
Measured after wound care on Study Day 1.
Title
Child Health Questionnaire
Description
Child Health Questionnaire The Child Health Questionnaire (CHQ) is a family of generic QOL instruments. The CHQ includes 87 scales that consider the effects of children's health on family functioning, and specific scales such as behavior and self-esteem. The CHQ measures 14 unique physical and psychosocial concepts. Questionnaires will be self-completed by the outpatients or parents, or both. Raw scores will converted to scaled scores from zero to 100. Higher scores indicate better health and better quality of life outcome.
Time Frame
measured at 0, 9 months and 12 month followup visits
Other Pre-specified Outcome Measures:
Title
Sullivans Pain Catastrophizing Scale for Children (Crombez et al., 2003).
Description
High catastrophizers are people who have unusually negative emotions and pessimistic beliefs about their ability to deal with the upcoming pain. Higher scores indicate worse outcome. 13 items, ratings from zero to 5 per item, 65 total points possible, 6 items measure helplessness, 3 items measure magnification, 4 items measure rumination subscores = 0-30 for helplessness, 0-15 for magnification, 0-20 for rumination. The PCS total score is calculated by summing the 13-item responses, and provides a good index of the catastrophizing construct through the inclusion of highly correlated subscales of helplessness, rumination, and magnification. Higher scores on the PCS are indicative of greater pain-related catastrophizing.
Time Frame
measured on Study day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter J Meyer, MD
Organizational Affiliation
UTMB/Shriners
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children; Shriners Burns Hospital
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers. Any data shared with other researchers will be in unidentifiable form.
Citations:
PubMed Identifier
21264690
Citation
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.
Results Reference
background
PubMed Identifier
12927636
Citation
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.
Results Reference
background
Links:
URL
https://www.shrinershospitalsforchildren.org/galveston
Description
Shriners Hospitals for Children-Galveston
URL
http://www.vrpain.com
Description
www.vrpain.com

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Virtual Reality Analgesia for Pediatric Burn Survivors

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