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OpenTrials
Completed

NCT Number: NCT04544631

VR for Pediatric Burn Dressing Changes

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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Key information

Conditions

Pain Burns Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality game as adjunctive pain management tool

Other

A smart phone virtual reality-based pain alleviation tool (VR-PAT).

Primary outcomes

  1. Observed pain

    Time frame: 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.

  2. Patient self-reported pain

    Time frame: 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 outcomes

  1. VR experience self-reported by patient and parents

    Time frame: 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"

  2. Simulator sickness symptoms of patient

    Time frame: 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".

  3. Nurse reported feasibility of VR in clinical burn wound care

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2020
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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