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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05466994
Eligibility Criteria:
Inclusion Criteria:
1. Ages 5-15
2. English and Spanish-speaking parents/legal guardians and patients
3. Undergoing major surgery for cancer requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
4. Expected to be prescribed postoperative inpatient opioids
5. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
7. Both the child and a legal guardian are willing and able to provide informed consent.
* The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (\>15 years of age) were disinterested in the interactive game.
Exclusion Criteria:
1. Patients with any daily opioid use within 30 days before surgery.
2. History of documented peripheral neuropathy secondary to cancer treatment
3. Inability to demonstrate an understanding of the game from English instructions
4. Any additional concerns based on the study physicians' assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT05466994
Study Brief:
Protocol Section:
NCT05466994