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:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT03435367
Eligibility Criteria:
Inclusion criteria will be:
1. aged 8-17 years
2. able to speak and understand English
3. parent/guardian present
4. medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
5. requires IV insertion
Exclusion criteria will be:
1. visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
2. psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
3. skin, face or ear infections or injuries, which could contaminate the intervention equipment
4. medically unstable (CTAS 1; patient requires immediate IV insertion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT03435367
Study Brief:
Protocol Section:
NCT03435367