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

NCT02986464 | Completed

• 1 other identifier: 2017-1382
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual reality; Immersive distraction; Virtual world; Virtual environment; Procedural pain; Acute pain; Pain Management; Children, Child; Kid, Kids; Pediatric, Pediatrics; Young children; Burns; Burn injuries; Burn unit; Hydrotherapy; Burn dressing; Non-pharmacological; Clinical Research; Nursing Practice

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score

  French version of the Face, Legs, Activity, Cry and Consolability (FLACC)

  T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)

Secondary Outcomes (5)

• Mean Pain Score - Observational/Behavioral Complementary measure

  T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)

• Comfort

  T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)

• Sedation

  T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)

• Health professionals' satisfaction level

  T4: immediately after the procedure before leaving the hydrotherapy room

• Analgesic requirement

  T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)

Study Arms (2)

Standard pharmacological treatment

ACTIVE COMPARATOR

Other: Standard Pharmacological Treatment

Virtual Reality distraction

EXPERIMENTAL

Device: Virtual Reality Prototype

Interventions

Virtual Reality Prototype DEVICE

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.

Virtual Reality distraction

Standard Pharmacological Treatment OTHER

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

Standard pharmacological treatment

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• suffer from a burn injury requiring a hydrotherapy session
• presence of a consenting parent who can understand, read and write either French or English

You may not qualify if:

• Requiring intensive care
• Having a diagnosed cognitive impairment
• Are unconscious or intubated during the hydrotherapy sessions
• Suffering from epilepsy (considering the nature of the intervention)
• Allergic to opioids or other analgesics used for standard pharmacological treatment
• Having burn injuries on the face preventing them from looking at the VR screen
• Will be excluded in posteriori from analysis children sedated for more than 50% of the time during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation Scale).

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste. Justine

Montreal, Quebec, H3T 1C4, Canada

Location

Related Publications (1)

• Khadra C, Ballard A, Paquin D, Cotes-Turpin C, Hoffman HG, Perreault I, Fortin JS, Bouchard S, Theroux J, Le May S. Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial. Burns. 2020 Nov;46(7):1571-1584. doi: 10.1016/j.burns.2020.04.006. Epub 2020 May 7.

  PMID: 32389349 DERIVED

MeSH Terms

Conditions

Burns; Pain; Pain, Procedural; Acute Pain; Agnosia; Deafness, Autosomal Recessive 1A

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Christelle Khadra, RN, PhD (c)

  Université de Montreal; CHU Ste-Justine Research Center

  PRINCIPAL INVESTIGATOR

• Sylvie Le May, RN, PhD

  Université de Montreal; CHU Ste-Justine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Professor, Université de Montréal

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: May 3, 2018
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)