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 Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use
NCT05589857CI-TRIAL-00081874withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No Patients Enrolles
Summary
Brief summary (as posted)
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented Reality | Device | — | UNRESOLVED |
| IPAD | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (Spellbound)
- description
- Participants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.
- interventionNames
- Device: IPAD
- type
- EXPERIMENTAL
- label
- Group 2 (Spellbound)
- description
- Participants will play the game using augmented reality.
- interventionNames
- Device: Augmented Reality
Primary outcomes (1)
- measure
- Pediatric Quality of Life Inventory
- 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 surgery 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. Prescribed daily opioids for pain for a period equal to or longer than 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. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery 2. Inability to demonstrate an understanding of the game from English instructions 3. Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
References
Publications (0)
Data not yet available
No reference posted for this study.