Status:
UNKNOWN
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
Lead Sponsor:
ALTality, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
M.D. Anderson Cancer Center
Conditions:
Pediatric Cancer
Surgery
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief Summary
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
Eligibility Criteria
Inclusion
- Ages 3-18
- English speaking parents/legal guardians and patients
- Undergoing major surgery for cancer requiring postoperative hospitalization defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- Expected to be prescribed postoperative inpatient opioids
- Have never taken opioids or have had no daily opioid use within the last 30 days
- Sufficient cognitive capacity to comprehend and interact with the game. This is defined as 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.
- Both child and a legal guardian are willing and able to provide informed consent.
Exclusion
- History of documented peripheral neuropathy secondary to cancer treatment
- Inability to demonstrate an understanding of the game from English instructions
- Have previous played the ARISETM digital scavenger hunt game
- Any additional concerns based on the study physicians' assessments
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04674150
Start Date
January 13 2021
End Date
November 30 2021
Last Update
August 16 2021
Active Locations (2)
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1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030