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 range6 Years – 11 Years
SexALL
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)
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