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N/A N=18 Treatment

Virtual Reality Distraction for Procedural Pain Management and Anxiety in Children With Burn Injuries : A Pilot Study

Burn · Child · Pain · Anxiety

Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Acceptability — 68.7; 55.6; 68.7; 85.9 percentage of healthcare responses

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Virtual Reality Distraction (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
St. Justine's Hospital
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Acceptability
68.7; 55.6; 68.7; 85.9; 91.3; 90.2
SECONDARY
Pain Intensity
2.0; 2.1; 2.9; 2.6; 1.0
SECONDARY
Anxiety Level
14.0; 11.7; 12.3; 8.0
SECONDARY
Comfort Level
2.9
SECONDARY
Number of Participants With Additional Analgesic Requirement
3
SECONDARY
Sedation Level
2; 2; 2

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.

Eligibility Criteria

Inclusion Criteria

  • Burn injury requiring hydrotherapy session.
  • Presence of a consenting parent who can understand, read and write either French or English.

Exclusion Criteria

  • Admitted to the intensive care Unit
  • Neuro-cognitive disability that precludes children from interacting with the distraction intervention
  • Unconscious or intubated during hydrotherapy session
  • Suffering from epilepsy (considering the nature of the intervention)
  • Allergic to opioids or other analgesics used for standard pharmacological treatment
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02794103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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