Back to resultsVR for Pediatric Burn Dressing Changes
Primary Purpose
Pain, Burns
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality game as adjunctive pain management tool
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pediatrics, Burns, Pain, Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- children age 6-17 years (inclusive)
- admitted or seen in the outpatient clinic for a burn injury
- spoke English as primary language
Exclusion Criteria:
- a severe burn on the face or head that prevented the utilization of the VR
- cognitive or motor impairment that prevented valid administration of study measures
- visual or hearing impairments that prevented interaction with the VR environment
- did not have a legal guardian present to give consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Active VR
Passive VR
Standard Care Control
Arm Description
Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure.
Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game.
Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking.
Outcomes
Primary Outcome Measures
Observed pain
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
Patient self-reported pain
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
Secondary Outcome Measures
VR experience self-reported by patient and parents
Self-reported virtual reality experience using patient and parent survey questions (5-6 survey items) about their experience in using virtual reality during burn wound care. Questions are a mixture of yes/no and a 100 Visual Analog Scale (VAS) with 0 being "Not at All" and 100 being "Very Much"
Simulator sickness symptoms of patient
Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of "None", "Slight", "Moderate", and "Severe".
Nurse reported feasibility of VR in clinical burn wound care
Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
Full Information
NCT ID
NCT04544631
First Posted
September 1, 2020
Last Updated
January 28, 2021
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04544631
Brief Title
VR for Pediatric Burn Dressing Changes
Official Title
Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
March 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
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
This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burns
Keywords
Pediatrics, Burns, Pain, Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, three-group between subject randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Researchers and nurses did not know the group assignment until immediately prior to intervention. Following the dressing change procedure, a second researcher, blinded to the group assignment, asked participants a post-assessment that included questions about child and guardian perceived pain and subjective VR experience.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active VR
Arm Type
Experimental
Arm Description
Participants in the active VR group played a virtual reality game entitled "Virtual River Cruise". In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced "cooling" experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure.
Arm Title
Passive VR
Arm Type
Experimental
Arm Description
Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game.
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking.
Intervention Type
Other
Intervention Name(s)
Virtual reality game as adjunctive pain management tool
Intervention Description
A smart phone virtual reality-based pain alleviation tool (VR-PAT).
Primary Outcome Measure Information:
Title
Observed pain
Description
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
Time Frame
During outpatient burn dressing change, on average lasting about 15 minutes.
Title
Patient self-reported pain
Description
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
Time Frame
During outpatient burn dressing change, on average lasting about 15 minutes.
Secondary Outcome Measure Information:
Title
VR experience self-reported by patient and parents
Description
Self-reported virtual reality experience using patient and parent survey questions (5-6 survey items) about their experience in using virtual reality during burn wound care. Questions are a mixture of yes/no and a 100 Visual Analog Scale (VAS) with 0 being "Not at All" and 100 being "Very Much"
Time Frame
During outpatient burn dressing change, on average lasting about 15 minutes.
Title
Simulator sickness symptoms of patient
Description
Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of "None", "Slight", "Moderate", and "Severe".
Time Frame
During outpatient burn dressing change, on average lasting about 15 minutes.
Title
Nurse reported feasibility of VR in clinical burn wound care
Description
Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
Time Frame
During outpatient burn dressing change, on average lasting about 15 minutes.
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:
children age 6-17 years (inclusive)
admitted or seen in the outpatient clinic for a burn injury
spoke English as primary language
Exclusion Criteria:
a severe burn on the face or head that prevented the utilization of the VR
cognitive or motor impairment that prevented valid administration of study measures
visual or hearing impairments that prevented interaction with the VR environment
did not have a legal guardian present to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Xiang, MD, MPH, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD are confidential patient data so we are not allowed to share the data with other researchers
Citations:
PubMed Identifier
34152420
Citation
Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.
Results Reference
derived
Learn more about this trial
VR for Pediatric Burn Dressing Changes
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