CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Virtual Reality Distractiondevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02794103
NCT02794103N/ACompleted

A Pilot Study to Assess the Feasibility and the Preliminary Efficacy of a Virtual Reality Distraction Intervention for Pain Management and Anxiety in Children With Burn Injuries During Hydrotherapy

St. Justine's Hospital·interventional·Posted Jun 8, 2016·Updated Sep 26, 2019

In Brief

A clinical study evaluating Virtual Reality Distraction for Burn and 3 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality (VR) is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries. The aim of this study is to assess the feasibility and preliminary efficacy of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain and anxiety in children with burn injuries. HYPOTHESES: a) VR distraction is a feasible non-pharmacological intervention for pain management during hydrotherapy, b) VR distraction combined with analgesics is more efficacious than standard treatment (analgesics alone) on procedural pain and anxiety (hydrotherapy) of young children with burn injuries.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 8, 2016
Enrollment StartJun 1, 2016
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.1 years ago

Interventions

Virtual Reality Distractiondevice

VR prototype developed by the SAT will be used as the experimental intervention. It has a wide screen installed at the end of the hydrotherapy tank offering a 150-degree field view, on which appears a game allowing the child to have the immersive entertainment experience without the need to wear a helmet or 3D glasses. The child or a proxy, depending on age and burn site, will have the opportunity to interact with the game. The interactive component is not mandatory for the immersive and distractive experiences provided by the prototype. Video games tailored to the child's age and injury, different from the commercially available ones, will be adapted to each age-group of children recruited with control over the speed of movement to avoid motion sickness.