VR for Pediatric Burn Dressing Changes
- Conditions
- PainBurns
- Interventions
- Other: Virtual reality game as adjunctive pain management tool
- Registration Number
- NCT04544631
- Lead Sponsor
- Nationwide Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- children age 6-17 years (inclusive)
- admitted or seen in the outpatient clinic for a burn injury
- spoke English as primary language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active VR Virtual reality game as adjunctive pain management tool 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. Passive VR Virtual reality game as adjunctive pain management tool 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.
- Primary Outcome Measures
Name Time Method Observed pain During outpatient burn dressing change, on average lasting about 15 minutes. 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 During outpatient burn dressing change, on average lasting about 15 minutes. Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
- Secondary Outcome Measures
Name Time Method Nurse reported feasibility of VR in clinical burn wound care During outpatient burn dressing change, on average lasting about 15 minutes. Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
VR experience self-reported by patient and parents During outpatient burn dressing change, on average lasting about 15 minutes. 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 During outpatient burn dressing change, on average lasting about 15 minutes. Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of "None", "Slight", "Moderate", and "Severe".