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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT03014466
Eligibility Criteria:
Inclusion Criteria:
Participants must:
1. be between ages of 4-10 years of age
2. have comprehension of instructions in the English language
3. have parental consent
4. Pediatric patient must be undergoing non-emergent outpatient surgery at Lucile Packard Children's Hospital
5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II) -
Exclusion Criteria:
General Exclusion Criteria are as follows:
1. Significant cognitive impairment/developmental delays per parental report or H\&P.
2. Children with ASA III, ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive \>24hours or without the operation)
3. Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
4. Strong parental or patient preference for pharmacological anxiolytic
5. Strong parental or patient preference for specific anxiety-reducing technique
6. Children born before 32 week gestation
7. Any indication that the patient may be admitted post-operatively
8. Child has had previous surgery or has undergone general anesthesia
9. Parent does not want to be present during transport to the OR or during induction -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT03014466
Study Brief:
Protocol Section:
NCT03014466