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

NCT02794103 | Completed Results

• 1 other identifier: 3943
• Study Type: interventional
• Target: 18
• 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 (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

Burn; Child; Pain; Anxiety

Keywords

Virtual reality; Immersive distraction; Virtual world; Virtual environment; Procedural pain; Procedural anxiety; Acute pain; Pain management; Anxiety; 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)

• Acceptability

  To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR prototype during the hydrotherapy session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).

  T4, immediately after the procedure before leaving the hydrotherapy room

Secondary Outcomes (5)

• Pain Intensity

  T1, 30 minutes before the procedure (patient's room); T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session

• Anxiety Level

  T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session

• Comfort Level

  T3, during the procedure (10 min after the beginning of the hydrotherapy session)

• Number of Participants With Additional Analgesic Requirement

  T3, during the procedure (10 min after the beginning of the hydrotherapy session)

• Sedation Level

  T2, before the procedure, upon arrival in the hydrotherapy room, T3, during the procedure (10 min after the beginning of the hydrotherapy session), T4, immediately after the procedure before leaving the hydrotherapy room

Study Arms (1)

Virtual Reality Distraction

EXPERIMENTAL

The child will visualize and interact with the virtual environment throughout the hydrotherapy session.

Device: Virtual Reality Distraction

Interventions

Virtual Reality Distraction DEVICE

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.

Virtual Reality Distraction

Eligibility Criteria

• Age: 2 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Société des Arts Technologiques (SAT), Montreal, Canada: collaborator
• Quebec Nursing Intervention Research Network: collaborator
• CHU Ste-Justine's Direction of Nursing, Montreal, Canada: collaborator
• Users Committee of CHU Ste-Justine, Montreal, Canada: collaborator
• Quebec Firefighters Foundation for Burns: collaborator

Study Sites (1)

CHU Ste. Justine

Montreal, Quebec, H3T 1C4, Canada

Location

MeSH Terms

Conditions

Burns; Pain; Anxiety Disorders; 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; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Dr. Sylvie Le May, Professor & Researcher
• Organization: Université de Montréal

sylvie.lemay@umontreal.ca

514 345-4931

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: June 8, 2016
• Study Start: June 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-08

Locations

CA (1)