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NCT05466994CompletedPhase 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)

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
29 (actual)
First submitted
18 Jul 2022
Start date
19 Aug 2022
Primary completion date
13 Jan 2026
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT05466994

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 29
  • From 19 Aug 2022 to the primary completion date, 13 Jan 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with any daily opioid use within 30 days before surgery.

Other illness

  • History of documented peripheral neuropathy secondary to cancer treatment

Other

  • Inability to demonstrate an understanding of the game from English instructions
  • Any additional concerns based on the study physicians' assessments

Who the study is looking for

  • 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.

Age in the registry: 5 years to 15 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Texas Children's Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.