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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT04942561
Eligibility Criteria:
Inclusion Criteria for Children:
1. Children who are 10-21 years old
2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
3. Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
4. Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
Inclusion criteria for healthcare providers:
1. Healthcare providers must be 18 years old or older
2. Healthcare providers must be Children's Hospital Los Angeles staff
3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure
Exclusion Criteria:
1. Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
2. Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
3. Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
4. Children with a history of seizure disorder.
5. Children currently sick with flu-like symptoms or experiencing a headache or earache.
6. Children with known or suspected motion sickness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT04942561
Study Brief:
Protocol Section:
NCT04942561