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

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ClinicalTrials.gov Identifier: NCT02794103
Recruitment Status : Completed
First Posted : June 8, 2016
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Société des Arts Technologiques (SAT), Montreal, Canada
Quebec Nursing Intervention Research Network
CHU Ste-Justine's Direction of Nursing, Montreal, Canada
Users Committee of CHU Ste-Justine, Montreal, Canada
Quebec Firefighters Foundation for Burns
Information provided by (Responsible Party):
Sylvie Le May, St. Justine's Hospital

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.


Condition or disease Intervention/treatment Phase
Burn Child Pain Anxiety Device: Virtual Reality Distraction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Feasibility and the Preliminary Efficacy of a Virtual Reality Distraction Intervention for Pain Management and Anxiety in Children With Burn Injuries During Hydrotherapy
Actual Study Start Date : June 2016
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Reality Distraction
The child will visualize and interact with the virtual environment throughout the hydrotherapy session.
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.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: T4, immediately after the procedure before leaving the hydrotherapy room ]
    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).


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 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 ]

    Face, Legs, Activity, Cry and Consolability (FLACC)- Behavioral pain assessment scale for children from 0 to 18 years old that includes five separate items with each item scored on a range from 0 to 2 to provide a total score of pain from 0 to 10.

    Interpretation: 0= relaxed and comfortable, 1-3= Mild discomfort, 4-6= Moderate pain, and 7-10 = severe discomfort/pain.


  2. Anxiety Level [ Time Frame: 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 ]
    Procedure Behaviour Check List (PBCL)- a behavioral scale that assesses anxiety based on 8 behaviors: muscular tension, screaming, crying, use of restraints, verbalization of pain, verbalization of anxiety, verbal stalling, and physical resistance. Each behavior is evaluated on a scale ranging from 1 (very slightly) to 5 (extremely intense) for a possible final score between 8 and 40, with a value of 8 meaning least anxious and 40 = most anxious.

  3. Comfort Level [ Time Frame: T3, during the procedure (10 min after the beginning of the hydrotherapy session) ]
    Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO) - an observational scale that assesses comfort during hydrotherapy procedure with scores ranging from 0 to 10: 0 = most comfortable, 10 = least comfortable.

  4. Number of Participants With Additional Analgesic Requirement [ Time Frame: T3, during the procedure (10 min after the beginning of the hydrotherapy session) ]
    Number of Participants who needed additional (rescue dose) medication administration

  5. Sedation Level [ Time Frame: 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 ]
    Ramsay sedation scale - ranging from 1 (anxious or restless or both) to 6 (no response to stimulus)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794103


Locations
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Canada, Quebec
CHU Ste. Justine
Montreal, Quebec, Canada, H3T 1C4
Sponsors and Collaborators
St. Justine's Hospital
Société des Arts Technologiques (SAT), Montreal, Canada
Quebec Nursing Intervention Research Network
CHU Ste-Justine's Direction of Nursing, Montreal, Canada
Users Committee of CHU Ste-Justine, Montreal, Canada
Quebec Firefighters Foundation for Burns
Investigators
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Principal Investigator: Sylvie Le May, PhD St. Justine's Hospital
  Study Documents (Full-Text)

Documents provided by Sylvie Le May, St. Justine's Hospital:
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Responsible Party: Sylvie Le May, RN, PhD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02794103    
Other Study ID Numbers: 3943
First Posted: June 8, 2016    Key Record Dates
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019
Last Verified: August 2019
Keywords provided by Sylvie Le May, St. Justine's Hospital:
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
Additional relevant MeSH terms:
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Burns
Anxiety Disorders
Mental Disorders
Wounds and Injuries