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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02794103 |
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Date of registration:
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15/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02794103 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sylvie Le May, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Justine's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Months
Age maximum:
10 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Burn
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Pain
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Anxiety
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Child
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Intervention(s)
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Device: Virtual Reality Distraction
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Primary Outcome(s)
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Acceptability
[Time Frame: T4, immediately after the procedure before leaving the hydrotherapy room]
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Secondary Outcome(s)
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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]
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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]
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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]
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Comfort Level
[Time Frame: T3, during the procedure (10 min after the beginning of the hydrotherapy session)]
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Number of Participants With Additional Analgesic Requirement
[Time Frame: T3, during the procedure (10 min after the beginning of the hydrotherapy session)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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