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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT03671057
Eligibility Criteria:
Inclusion Criteria:
* Children from 4 up to (and included) 7 years old. The children represent a large group within the otorhinolaryngeal discipline and these children are within the same cognitive phase when it comes to playing a serious game
* Children who need otorhinolaryngeal surgery for the first time.
* Children and at least one of the parents are able to comprehend and speak the Dutch language.
* Children who will receive a mask induction of the anaesthesia.
Exclusion Criteria:
* Older and younger children than the mentioned age group.
* Children who do not have a complete comprehension of the Dutch language. Children will not be excluded based on cultural or background information.
* Children who had previous surgical experiences both elective or urgent.
* The following children will also be excluded from participation: children with mental retardation, children that have had opioids or sedative during the past month, children with early birth, children with behavioural dysfunction and children with a delayed cognitive development.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
7 Years
Study:
NCT03671057
Study Brief:
Protocol Section:
NCT03671057