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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04291404
Eligibility Criteria:
We will include children presenting to the Stollery Children's Hospital ED, based on the eligibility criteria outlined below:
Inclusion Criteria:
1. child aged 6-17 years
2. requires IV placement
3. will receive topical anesthetic cream for IV placement
Exclusion Criteria:
1. medically unstable (CTAS 1, requires immediate IV insertion)
2. unconscious or not fully alert
3. visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention
4. conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy
5. presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization
6. screens positive for 'influenza-like illness' (ILI) as per the current SCH ED screening criteria
7. child or parental language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
8. previous enrollment in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04291404
Study Brief:
Protocol Section:
NCT04291404