Clinical trial · Interventional
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)
NCT05466994CI-TRIAL-00100935completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented Reality | Other | — | UNRESOLVED |
| IPAD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1(Spellbound)
- description
- Participants will play the game using the iPad's standard camera, which will show you your hospital room and the decals as they appear in the real world.
- interventionNames
- Other: IPAD
- type
- OTHER
- label
- Group 2 (Spellbound)
- description
- Participants will play the game using augmented reality
- interventionNames
- Other: Augmented Reality
Primary outcomes (1)
- measure
- Pediatric Quality of Life Inventory Questionnaires
- timeFrame
- through completion of study, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages 5-15 2. English and Spanish-speaking parents/legal guardians and patients 3. 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 4. Expected to be prescribed postoperative inpatient opioids 5. Have never taken opioids or have had no daily opioid use within the last 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. Patients with any daily opioid use within 30 days before surgery. 2. History of documented peripheral neuropathy secondary to cancer treatment 3. Inability to demonstrate an understanding of the game from English instructions 4. Any additional concerns based on the study physicians' assessments
References
Publications (1)
- DERIVEDCata JP, Guerra-Londono JJ, Aveni P, Cortes-Mejia N, Gloria JM, Choi JE, Kim Hye M, Owusu-Agyemang P, Feng L, Fuller C, Beel ER, Sinton J. A Pilot Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naive Undergoing Surgery to Reduce Postoperative Opioid Use (The GAMING-ON Study). Paediatr Anaesth. 2026 Apr;36(4):352-360. doi: 10.1002/pan.70109. Epub 2025 Dec 22. PMID 41427500