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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05589857
Eligibility Criteria:
Inclusion Criteria:
1. Ages 5-15
2. English and Spanish-speaking parents/legal guardians and patients
3. Undergoing surgery 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. Prescribed daily opioids for pain for a period equal to or longer than 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. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
2. Inability to demonstrate an understanding of the game from English instructions
3. Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT05589857
Study Brief:
Protocol Section:
NCT05589857