Clinical trial · Interventional
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
A Pilot Randomized Controlled Trial to Determine the Feasibility of Administering an auGmented reAlity gaMe to pediatrIc caNcer Patients underGoing Surgery (A GAMING Study)
NCT04674150CI-TRIAL-00053281GAMINGunknownPhase 1ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARISE with AR | Device | — | UNRESOLVED |
| ARISE without AR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Non-AR Group
- description
- Patients allocated to the control group will be able to interact with the iPad and visualize objects and decals in the walls but not able to initiate the AR technology. In other terms, patients in this group will be provided with the same iPad to the AR group patients with the only exception that the AR technology will be off and will only see objects through the device camera in normal reality.
- interventionNames
- Device: ARISE without AR
- type
- ACTIVE_COMPARATOR
- label
- AR Group
- description
- Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game.
- interventionNames
- Device: ARISE with AR
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages 3-18 2. English speaking parents/legal guardians and patients 3. 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 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 6. 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. 7. Both child and a legal guardian are willing and able to provide informed consent. Exclusion Criteria: 1. History of documented peripheral neuropathy secondary to cancer treatment 2. Inability to demonstrate an understanding of the game from English instructions 3. Have previous played the ARISETM digital scavenger hunt game 4. Any additional concerns based on the study physicians' assessments
References
Publications (0)
Data not yet available
No reference posted for this study.