AR Tool for Post-Surgery Symptoms in Pediatric Cancer Patients

Overseen By Juan Cata, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Opioids

Disqualifiers: Parental refusal, Investigator concerns

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an augmented reality (AR) tool can help track pain, nausea, and vomiting in children who have undergone cancer surgery. Participants will use a device that combines real-world views with digital images to determine if it aids in reporting their symptoms. The trial includes children aged 7 to 17 who have cancer or a benign tumor, are undergoing surgery lasting over two hours, and can understand English or Spanish. As an unphased trial, this study provides a unique opportunity to explore innovative technology that could enhance symptom tracking and management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that virtual reality (VR), similar to augmented reality (AR), is usually safe for children. Studies found that side effects were rare and typically resolved on their own. VR and AR use devices to add digital images to the real world, making them fun and engaging for kids.

In medical settings, these technologies have shown promise. They help children feel more in control and can make medical experiences less stressful. With the right equipment and careful patient selection, AR is considered low-risk and well-tolerated. This makes it a promising option for helping kids after surgery, especially in managing symptoms like pain or nausea.

In summary, AR is generally safe for children and can be a helpful tool in medical care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using augmented reality (AR) for managing post-surgery symptoms in pediatric cancer patients because it represents a new way to engage young patients in their recovery. Unlike traditional methods that might involve medications for pain management or physical therapies, AR creates an immersive experience where digital characters and items interact with the real world through a screen. This approach not only makes the healing process more engaging for children but may also reduce anxiety and improve adherence to rehabilitation activities. By integrating fun and familiarity into their recovery, AR has the potential to enhance both mental and physical well-being in a way that traditional treatments might not.

What evidence suggests that this AR tool is effective for post-surgery symptoms in pediatric cancer patients?

Research has shown that augmented reality (AR), which participants in this trial will experience, can help manage pain and anxiety in children. Studies have found that hospitals can use AR to reduce pain and the need for pain medicine after surgery. Patients and caregivers have reported high satisfaction with AR, with most recommending its use. Although more research is needed to confirm these benefits, early results are promising for enhancing children's comfort and emotional well-being after surgery. ^{5 6 7 8 9}

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 English or Spanish-speaking kids aged 7-17 with cancer who are having surgery lasting over 2 hours and will need painkillers like opioids after. They must be able to understand and use the game in the study, and have a guardian's consent. Kids can't join if their doctor thinks the app isn't right for them or if parents don't agree.

Inclusion Criteria

My surgery is expected to last more than 2 hours.

I am currently diagnosed with cancer or a non-cancerous tumor as a child.

I can understand and interact in English or Spanish.

Exclusion Criteria

Any concerns from the principal investigator or primary team about the use of the app

Inability or refusal from the parents to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use an AR-based electronic tool to assess postoperative pain, nausea, and vomiting

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Augmented reality (AR)

Trial Overview The study is testing how well an electronic tool works when used by kids recovering from cancer surgery to report their pain, nausea, and vomiting. It uses augmented reality (AR) technology to help measure these postoperative conditions.

How Is the Trial Designed?

Group I: Augmented reality (AR) Experimental Treatment 1 Intervention

Augmented reality (AR) Participants will view the real world through a device's camera and application ("app") but adds virtual or digital characters and items to the image

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

Published Research Related to This Trial

In a pilot study involving 30 adolescents with cancer undergoing lumbar punctures, the use of virtual reality (VR) glasses showed a trend towards lower pain scores compared to a control group, although the difference was not statistically significant.

77% of the adolescents using VR reported that it helped distract them from the procedure, suggesting that VR could be a useful nonpharmacologic tool for pain management during painful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Sander Wint, S., Eshelman, D., Steele, J., et al.[2022]

Extended reality (XR) technology, including virtual and augmented reality, is being increasingly used in pediatric intensive care to enhance medical education and improve patient outcomes, particularly in reducing pain and anxiety.

Research shows that XR is a safe and feasible intervention for pediatric patients in intensive care, with significant applications in both clinical interventions and medical education, particularly over the past five years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Reality Use in Paediatric Intensive Care: A Scoping Review. Goldsworthy, A., Chawla, J., Baumann, O., et al.[2023]

An augmented reality (AR) navigation system was developed for pediatric endoscopic surgery, allowing for improved detection and resection of tumors in six patients aged 3.5 years on average, with various tumor types and sizes.

All tumors were successfully detected and resected using the AR system without any complications, demonstrating its efficacy and safety in enhancing surgical precision in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An augmented reality navigation system for pediatric oncologic surgery based on preoperative CT and MRI images. Souzaki, R., Ieiri, S., Uemura, M., et al.[2019]

In a study involving 22 children with tumors, a virtual reality (VR) intervention significantly reduced distress levels during painful medical procedures compared to no VR, with median distress scores of 2 versus 4.

While the VR intervention did not show a measurable impact on anxiety levels, it was highly accepted by children and their families, suggesting potential for routine clinical use, though further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a VR Intervention to Decrease Anxiety in Children with Tumors Undergoing CVC Dressing. Russo, L., Tozzi, AE., Mastronuzzi, A., et al.[2023]

A smartphone augmented reality (AR) app was developed for presurgical planning and localization of brain tumors, showing a mean Euclidean distance of virtual object displacement of 4.7 mm in a 3D-printed model, indicating good accuracy.

In clinical validation with 14 patients, the AR app demonstrated satisfactory localization accuracy for tumors larger than 15 mm, with a mean maximum margin distance of 6.7 mm and an area overlap ratio of 79%, making surgical planning more intuitive and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time augmented reality application in presurgical planning and lesion scalp localization by a smartphone. Shu, XJ., Wang, Y., Xin, H., et al.[2022]

Virtual reality (VR) and augmented reality (AR) technologies enhance neurosurgical planning and execution by providing improved visualization of complex brain anatomy and better localization of tumors during surgery, as shown in a review of 19 studies.

When compared to traditional neuronavigation systems, VR/AR demonstrated quantitative clinical benefits, suggesting they could significantly improve outcomes in neurosurgical procedures for cranial tumor resections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presurgical and Intraoperative Augmented Reality in Neuro-Oncologic Surgery: Clinical Experiences and Limitations. Mikhail, M., Mithani, K., Ibrahim, GM.[2020]

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]

Augmented Reality (AR) has the potential to reduce fear in children undergoing minor otolaryngologic procedures by allowing them to maintain eye contact with comforting parents while being distracted by holographic images.

The study also aimed to assess pain levels, procedure compliance, and attitudes towards AR from patients, parents, and physicians, highlighting the feasibility of integrating AR into busy outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Augmented Reality to Reduce Fear and Promote Cooperation During Pediatric Otolaryngologic Procedures. Caruso, TJ., Madill, M., Sidell, D., et al.[2021]

Extended reality (XR) technologies, including virtual reality and augmented reality, have shown promising benefits in neurosurgery, particularly in preoperative planning and improving tumor resection rates, with 34% of studies reporting enhanced functional outcomes.

Despite the potential advantages of XR in neurosurgery, there is a notable lack of high-quality controlled studies focusing on patient outcomes, indicating a need for further research to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the benefits of extended reality in neurosurgery: A systematic review. Dadario, NB., Quinoa, T., Khatri, D., et al.[2021]

A systematic review of six randomized controlled trials involving 529 children aged 4-12 showed that virtual reality significantly reduces preoperative anxiety, with a strong effect size (SMD: -0.91).

The use of virtual reality also improved children's compliance with anaesthesia, indicating that familiarizing them with the operating room environment can enhance their overall experience before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on preoperative anxiety in children: A systematic review and meta-analysis of randomised controlled trials. Chen, YJ., Wang, CJ., Chen, CW.[2023]

Immersive technology, particularly virtual reality, has been increasingly studied as a safe and effective non-drug option for managing perioperative anxiety and pain in children, with several studies showing positive results over the last three years.

Despite the promising findings, most studies have small sample sizes and varied methods, highlighting the need for more rigorous research, such as larger randomized controlled trials, to better understand the effectiveness and potential side effects of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Art: Immersive Technologies for Perioperative Anxiety, Acute, and Chronic Pain Management in Pediatric Patients. Alqudimat, M., Mesaroli, G., Lalloo, C., et al.[2022]

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