Pediatric ALLPhase 2NCT05466994
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)
A Phase 2 study testing IPAD and Augmented Reality in people with Pediatric ALL and Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Pediatric ALL, Cancer
- What is being tested?
- IPAD and Augmented Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2022to 13 Jan 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with any daily opioid use within 30 days before surgery.
- History of documented peripheral neuropathy secondary to cancer treatment
- Inability to demonstrate an understanding of the game from English instructions
- Any additional concerns based on the study physicians' assessments
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M D Anderson Cancer Center
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
Read the detailed description
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:
- Inpatient opioid use
- Average daily inpatient pain score
- Number of opioid requests during the hospital stay
- Inpatient PedsQL (quality of life) questionnaire score
- Ambulation/"out of bed" movement
- Number days to discharge-ready status
- Patient experience assessed by satisfaction scores on a questionnaire designed by MD Anderson Cancer Center Child Life team.
- Outpatient opioid consumption reported at 30, 60, and 90 days
- Outpatient pain scores reported at 30, 60, and 90 days
- Outpatient PedsQL scores reported at 30, 60, and 90 days
- Potential adverse events related to the use of AR (i.e., falls).
- Conditions
- Pediatric ALL, Cancer
- Being tested
- IPAD, Augmented Reality
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPADOther
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
Augmented RealityOther
Participants will play a game through (devices camera and application) let us participants view the real world
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IPAD |
| Group 2 (Spellbound) | Other | Participants will play the game using augmented reality Receives: Other: Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through completion of study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start19 Aug 2022
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Juan Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466994
- Sponsor's protocol ID
- 2022-0336
- Other IDs
- NCI-2022-05979
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41427500