Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial

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 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.

This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.

Conditions

• Burns
• Child
• Pain

Interventions

DEVICE

Virtual Reality Prototype

VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.

OTHER

Standard Pharmacological Treatment

According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and the pain clinic nurse.

Sponsors & Collaborators

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Christelle Khadra, RN, PhD (c) · Université de Montreal; CHU Ste-Justine Research Center

• Sylvie Le May, RN, PhD · Université de Montreal; CHU Ste-Justine Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Months

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-03

Primary Completion

2019-06-14

Completion

2019-06-14

Countries

• Canada

Study Locations