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

NCT02794103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-09-26

Study results available
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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.

Conditions

Interventions

DEVICE

Virtual Reality Distraction

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.

Sponsors & Collaborators

  • Société des Arts Technologiques (SAT), Montreal, Canada

    collaborator UNKNOWN
  • Quebec Nursing Intervention Research Network

    collaborator OTHER
  • CHU Ste-Justine's Direction of Nursing, Montreal, Canada

    collaborator UNKNOWN
  • Users Committee of CHU Ste-Justine, Montreal, Canada

    collaborator UNKNOWN
  • Quebec Firefighters Foundation for Burns

    collaborator OTHER
  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794103 on ClinicalTrials.gov