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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
- 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.
- 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.
- 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
- 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)
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
|CHU Ste. Justine|
|Montreal, Quebec, Canada, H3T 1C4|
|Principal Investigator:||Sylvie Le May, PhD||St. Justine's Hospital|