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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active VR | Experimental | 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. |
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| Passive VR | Experimental | 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. |
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| Standard Care Control | No Intervention | Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality game as adjunctive pain management tool | Other | A smart phone virtual reality-based pain alleviation tool (VR-PAT). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During outpatient burn dressing change, on average lasting about 15 minutes. |
| Patient self-reported pain | Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome. | During outpatient burn dressing change, on average lasting about 15 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | During outpatient burn dressing change, on average lasting about 15 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Xiang, MD, MPH, PhD | Nationwide Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34152420 | Result | 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. | |
| 35913793 |
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IPD are confidential patient data so we are not allowed to share the data with other researchers
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| ID | Term |
|---|---|
| D010146 | Pain |
| D002056 | Burns |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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A prospective, three-group between subject randomized controlled trial
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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.
| 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". | During outpatient burn dressing change, on average lasting about 15 minutes. |
| 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". | During outpatient burn dressing change, on average lasting about 15 minutes. |
| Vest E, Armstrong M, Olbrecht VA, Thakkar RK, Fabia RB, Groner JI, Noffsinger D, Tram NK, Xiang H. Association of Pre-procedural Anxiety With Procedure-Related Pain During Outpatient Pediatric Burn Care: A Pilot Study. J Burn Care Res. 2023 May 2;44(3):610-617. doi: 10.1093/jbcr/irac108. |
| 38271320 | Result | Jain S, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Nelson E, Xiang H. Features of virtual reality impact effectiveness of VR pain alleviation therapeutics in pediatric burn patients: A randomized clinical trial. PLOS Digit Health. 2024 Jan 25;3(1):e0000440. doi: 10.1371/journal.pdig.0000440. eCollection 2024 Jan. |
| 39091668 | Result | Jones K, Armstrong M, Luna J, Thakkar RK, Fabia R, Groner JI, Noffsinger D, Ni A, Griffin B, Xiang H. Age and Sex Differences of Virtual Reality Pain Alleviation Therapeutic During Pediatric Burn Care: A Randomized Clinical Trial. J Med Ext Real. 2024 Jul 24;1(1):163-173. doi: 10.1089/jmxr.2024.0004. eCollection 2024 Jul. |