Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT05066061
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT05066061
Study Brief:
Protocol Section:
NCT05066061