Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot … (NCT02977923) | Clinical Trial Compass
CompletedNot Applicable
Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study
Canada20 participantsStarted 2017-07-10
Plain-language summary
Children with injuries, including burns, experience severe pain intensity during medical procedures despite the increasing doses of analgesics. 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. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in wound care.
Overall hypothesis: Distraction by VR via the OR, in combination with the standard pharmacological treatment, is a feasible, acceptable and satisfactory method for the management of pain and anxiety during wound-related treatments in children with injuries.
Note that this pilot study will precede a larger trial aimed at assessing the effect of virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)
Who can participate
Age range
7 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* suffer from a burn or another injury requiring wound dressing change or physiotherapy
* presence of a consenting parent who can understand, read and write either French or English
Exclusion Criteria:
* Requiring intensive care
* Having a diagnosed cognitive impairment
* Are unconscious or intubated during dressing change or physiotherapy sessions
* Suffering from epilepsy (considering the nature of the intervention)
* Allergic to opioids or other analgesics used for standard pharmacological treatment
* Having injuries on the face preventing the use of the Oculus Rift helmet
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability
Timeframe: T4, immediately after the procedure completion, before leaving the procedure room