Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP) (NCT05066061) | Clinical Trial Compass
TerminatedNot Applicable
Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP)
Stopped: recruiting difficulties
France34 participantsStarted 2021-12-06
Plain-language summary
Main objective :
Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.
Hypothesis :
Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.
Who can participate
Age range
6 Years – 11 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:
* Children from 6 to 11 years old requiring an intravenous catheter insertion in a pediatric day hospital at the Clermont Ferrand University Hospital.
* Subjects and their parents who were informed about the study and gave informed consent
* Subjects who have had local anesthetic cream for 1-5 hours at the puncture site
* On the first attempt to apply intravenous catheter on the day of inclusion
* Subjects and their parents able to use the self-report scales proposed in the study.
Exclusion Criteria:
Children from 6 to 11 :
* Having a modification of pain's integration (spina bifida for example)
* Having received an analgesic before the care
* Requiring contact isolation
* With a history of seizures or motion sickness
* Born very prematurely (\< 28 SA)
* Presenting a contraindication to the use of the local anesthetic cream
* Presenting a contraindication to the use of the anesthetic and anxiolytic gas.
* Presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post traumatic stress syndrome)
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
change from baseline child's pain at 30 minutes after the care
Timeframe: - Before the care - Immediately after the care - 15 to 30 minutes after the care