Augmented Reality Game for Pediatric Cancer

Not currently recruiting at 1 trial location

Overseen By Juan Cata, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Peripheral neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the augmented reality game SpellBound can reduce pain and opioid use in children after cancer surgery. Participants will use an iPad to interact with fun virtual elements in their hospital room. Children aged 5 to 15 who have not regularly used opioids and are undergoing major cancer surgery may qualify. The goal is to make recovery more comfortable and less dependent on medication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, contributing to innovative pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that participants have not used opioids daily in the last 30 days before surgery.

What prior data suggests that this augmented reality game is safe for pediatric cancer patients?

Research has shown that augmented reality games like SpellBound are generally safe for children. A review of 14 studies involving over 1,000 children in various medical settings, such as surgery and cancer treatment, found that these games can be used safely. The studies reported no serious side effects. As an augmented reality game, SpellBound does not involve drugs or surgery, typically resulting in fewer risks. The current trial is in Phase 2, indicating that some safety information is already available, but researchers continue to study its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the augmented reality game, SpellBound, as it offers a novel way to support pediatric cancer patients during treatment. Unlike traditional therapies that focus solely on medical interventions, this game provides an engaging and interactive experience that can help children cope with the emotional and psychological challenges of cancer. By using augmented reality, SpellBound transforms the hospital environment into a playful space, potentially reducing stress and anxiety. This innovative approach not only aims to improve the overall well-being of young patients but also enhances their hospital experience, making it a promising complementary tool in cancer care.

What evidence suggests that this augmented reality game is effective for reducing pain in pediatric cancer patients?

Research shows that the augmented reality game SpellBound can reduce the need for opioids in children after surgery. Studies have found that this game may decrease the need for pain medication in young cancer patients. Early results suggest that playing SpellBound might also help children leave the hospital sooner. A review of 14 studies involving over 1,000 children found that augmented reality had positive effects in various medical settings. These promising results suggest that SpellBound could effectively manage pain in children. Participants in this trial will be divided into two groups to play the game using different methods: one group will use the iPad's standard camera, while the other will experience the game through augmented reality. ^{1 4 5 6 7}

Who Is on the Research Team?

Juan Cata, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for children aged 5-15 with cancer, scheduled for major surgery requiring at least one night's hospital stay. They must be opioid-naïve, able to understand and interact with an iPad game, and have parents/guardians who can consent. Children over 15 or those with prior neuropathy or recent opioid use are excluded.

Inclusion Criteria

Both the child and a legal guardian are willing and able to provide informed consent.

I am expected to need strong painkillers after surgery.

I am scheduled for a major cancer surgery that requires staying in the hospital overnight.

Exclusion Criteria

Inability to demonstrate an understanding of the game from English instructions

Patients with any daily opioid use within 30 days before surgery.

Any additional concerns based on the study physicians' assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants play the SpellBound augmented reality game to assess its efficacy in reducing postoperative opioid use

90 days

Inpatient stay with daily monitoring

Follow-up

Participants are monitored for outpatient opioid consumption and pain scores at 30, 60, and 90 days

3 months

Outpatient assessments at 30, 60, and 90 days

Long-term follow-up

Quality of life and adverse events related to AR use are assessed

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality Game (SpellBound)

Trial Overview The study tests if a SpellBound augmented reality game on an iPad can help reduce pain and lessen the need for opioids in pediatric patients after surgery. It's a randomized controlled trial comparing game interaction outcomes against standard postoperative care.

How Is the Trial Designed?

Group I: Group 2 (Spellbound) Experimental Treatment 1 Intervention

Participants will play the game using augmented reality

Group II: Group 1(Spellbound) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A systematic review of six randomized controlled trials involving 379 pediatric cancer patients found that virtual reality (VR) significantly reduces pain, anxiety, and fear symptoms, indicating its efficacy as a supportive treatment.

The results showed a notable decrease in pain (mean difference of -4.82), anxiety (standardized mean difference of -1.47), and fear (mean difference of -1.25) when using VR, suggesting it can be a valuable tool in managing the psychological and physical discomfort of young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Cheng, Z., Yu, S., Zhang, W., et al.[2022]

From 2008 to 2012, the FDA recorded 113,077 adverse drug reactions (ADRs) in pediatric patients, with the majority of reports coming from medical doctors (32%) and consumers (26%).

The most commonly reported ADRs included pyrexia, convulsions, vomiting, and accidental overdoses, particularly associated with drugs affecting the nervous system and antineoplastic/immunomodulating agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System Database of the Food and Drug Administration. Bigi, C., Tuccori, M., Bocci, G.[2022]

The study highlights the importance of accurately reporting infectious adverse events (AEs) in children with acute lymphoblastic leukemia (ALL) to better manage safety and toxicity during clinical trials.

Key processes implemented in two phase III trials included targeted toxicity identification, specific case report forms for infections, and real-time physician review, which have shown preliminary improvements in the reporting of infectious AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. Elgarten, CW., Thompson, JC., Angiolillo, A., et al.[2023]

A game-based symptom-reporting app was used by 19 school-age children with cancer, showing preliminary feasibility with a median usage of 4 days, and high engagement with features like symptom reporting and drawing.

Both children and parents found the app acceptable, appreciating its interactive nature and the opportunity for children to express their symptoms creatively, suggesting it could enhance autonomy and decision-making in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. Linder, LA., Newman, AR., Stegenga, K., et al.[2023]

Active video gaming (AVG) was found to be a feasible and enjoyable way to promote regular physical exercise in children aged 7-17 who are survivors of brain tumors, with participants engaging in AVG for an average of 47 minutes on 72% of days.

The study showed a significant improvement in Body Coordination scores by 15% after 10-12 weeks of AVG, indicating that this intervention can enhance physical functioning in childhood brain tumor survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video gaming improves body coordination in survivors of childhood brain tumours. Sabel, M., Sjölund, A., Broeren, J., et al.[2022]

A study involving 257 children and adolescents with leukemia and lymphoma revealed that fatigue was the most severe adverse event reported both before and after treatment, affecting 68.1% of participants at the start and 67% after treatment.

Gastrointestinal symptoms, such as nausea and abdominal pain, were also prevalent, with little change in severity or interference over time, indicating that despite supportive care, many children continue to experience significant symptoms during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. Jacobs, SS., Withycombe, JS., Castellino, SM., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/NpH5qVDOQEGARzOqCRWC3g/project-details/10013076

Project Details - NIH RePORTER In Phase II, we will evaluate the efficacy of the game to reduce immediate and long-term postoperative opioid use in children with cancer undergoing major ...

2. spellboundar.com spellboundar.com/products/arise/research

ARISE Research — SpellBound AR: Pediatric Patient ... The study will measure the effects of SpellBound's augmented reality scavenger hunt, ARISE, on the length of hospital stay and opioid use by pediatric cancer ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05466994/a-phase-ii-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-gaming-on-study

A Phase II Randomized Controlled Trial to Determine the ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088259632500257X

Investigating the effects of augmented reality-based ... Results. The review included 14 studies involving 1057 children across diverse clinical settings such as surgery, oncology, dentistry, rehabilitation, and ...

5. texaschildrens.org texaschildrens.org/sites/default/files/uploads/documents/symposia/srd/2022/p23.pdf

A Pilot Randomized Controlled Trial to Assess the ... Our study demonstrates the feasibility of delivering an. AR scavenger hunt game in the postoperative period of pediatric patients undergoing oncological surgery ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05466994?tab=history&a=10

Record History | ver. 10: 2025-04-08 | NCT05466994 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05466994

Study Details | NCT05466994 | A Phase II Randomized ... 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 ...