A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)
Completed · Phase 2
Conditions studied: Pediatric ALL, Cancer
In brief
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
Key facts
- Study ID
- NCT05466994
- Run by
- M.D. Anderson Cancer Center
- People needed
- 29
- Starts
- 2022-08-19
- Expected to finish
- 2026-01-13
- Last updated by the study team
- 2026-01-15
Who can join
Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 5-15
- English and Spanish-speaking parents/legal guardians and patients
- 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
- Expected to be prescribed postoperative inpatient opioids
- Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
- 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.
- 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.
You may not qualify if…
- Patients with any daily opioid use within 30 days before surgery.
- History of documented peripheral neuropathy secondary to cancer treatment
- Inability to demonstrate an understanding of the game from English instructions
- Any additional concerns based on the study physicians' assessments
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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