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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05979 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
Primary Objective:
•To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial.
Secondary Objectives:
To assess the effect of AR versus non-AR control technology in pediatric oncology patients, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(Spellbound) | Other | 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. |
|
| Group 2 (Spellbound) | Other | Participants will play the game using augmented reality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPAD | Other | Participant will play a game through (standard camera) participants will be able to the hospital room and decals as they appear in the real world |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life Inventory Questionnaires | Quality of life assessment-Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status. Score scales (0-4) 0-Never/4 Almost Always | through completion of study, an average of 1 year |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Cata, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Texas Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41427500 | Derived | Cata 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. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2024 | Jan 14, 2026 |
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| Augmented Reality | Other | Participants will play a game through (devices camera and application) let us participants view the real world |
|
| Houston |
| Texas |
| 77030 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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