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

14 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Augmented reality (AR), Virtual Reality (VR), Mixed Reality (MR), Extended Reality (XR) for post-surgery symptoms in pediatric cancer patients?

Research shows that virtual reality (VR) can help reduce pain and anxiety in children with cancer during medical procedures, suggesting it might also help with post-surgery symptoms. Studies found that VR can lower distress levels and is well-received by children and their families. ^{1 2 3 4 5}

Is augmented reality safe for use in pediatric patients?

Research shows that virtual and augmented reality technologies are generally safe for pediatric patients, helping to reduce pain and anxiety in intensive care and during medical procedures. ^{1 2 6 7 8}

How does the AR tool for post-surgery symptoms in pediatric cancer patients differ from other treatments?

The AR tool is unique because it uses augmented reality (AR) to enhance visualization and navigation during surgery, which can help surgeons better detect and remove tumors in pediatric cancer patients. This approach is different from traditional methods as it provides a three-dimensional view of the anatomy, potentially improving surgical outcomes by offering real-time guidance. ^{1 2 9 10 11}

What is the purpose of this trial?

The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.

Research Team

Juan Cata, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

State of the Art: Immersive Technologies for Perioperative Anxiety, Acute, and Chronic Pain Management in Pediatric Patients. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a VR Intervention to Decrease Anxiety in Children with Tumors Undergoing CVC Dressing. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Extended Reality Use in Paediatric Intensive Care: A Scoping Review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Using Augmented Reality to Reduce Fear and Promote Cooperation During Pediatric Otolaryngologic Procedures. [2021]

8. Scotland pubmed.ncbi.nlm.nih.gov

Examining the benefits of extended reality in neurosurgery: A systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

An augmented reality navigation system for pediatric oncologic surgery based on preoperative CT and MRI images. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Presurgical and Intraoperative Augmented Reality in Neuro-Oncologic Surgery: Clinical Experiences and Limitations. [2020]

11. Austria pubmed.ncbi.nlm.nih.gov

Real-time augmented reality application in presurgical planning and lesion scalp localization by a smartphone. [2022]