CompletedPhase 2

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)

United States29 participantsStarted 2022-08-19

Plain-language summary

To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Age range5 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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

Pediatric Quality of Life Inventory Questionnaires

Timeframe: through completion of study, an average of 1 year

NCT IDNCT05466994

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-13

Who can participate

Age range5 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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