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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05466994
- Acronym / sponsor ID
- 2022-0336
- Conditions
- Pediatric ALL, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Spellbound) | Other | Other: IPADParticipants 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 | Other: Augmented RealityParticipants will play the game using augmented reality |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPADParticipant will play a game through (standard camera) participants will be able to the hospital room and decals as they appear in the real world | Other | Group 1(Spellbound) |
| Augmented RealityParticipants will play a game through (devices camera and application) let us participants view the real world | Other | Group 2 (Spellbound) |
Primary outcome
Pediatric Quality of Life Inventory Questionnaires
Time frame: through completion of study, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 41427500Cata 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.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Cata, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory Questionnaires (time frame: through completion of study, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.