40 Participants Needed

Virtual Reality for Acute Lymphoblastic Leukemia

(VIRALL Trial)

JL
AG
Overseen ByAlissa Groisser, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's National Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the focus is on using virtual reality instead of general anesthesia, it seems unlikely that you would need to stop other medications.

What data supports the effectiveness of the treatment Virtual Reality Therapy for Acute Lymphoblastic Leukemia?

Research shows that virtual reality can help reduce pain and anxiety in children with cancer, including those receiving treatments like chemotherapy. It provides a fun and engaging distraction, making medical procedures less stressful and more comfortable for young patients.12345

Is Virtual Reality Therapy safe for humans?

There is no specific safety data available for Virtual Reality Therapy in the context of acute lymphoblastic leukemia, but general safety information for VR therapy in other conditions suggests it is generally safe for humans.678910

How is Virtual Reality Therapy different from other treatments for acute lymphoblastic leukemia?

Virtual Reality Therapy is unique because it uses immersive technology to potentially help manage symptoms and improve the quality of life for patients, rather than directly targeting the leukemia cells like traditional chemotherapy or stem cell transplantation.1112131415

What is the purpose of this trial?

Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.

Eligibility Criteria

This trial is for children and adolescents over 7 years old with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of treatment. They must be scheduled to receive spinal taps as part of their therapy but cannot participate if they have conditions that make VR use unsafe or have had previous adverse reactions to local anesthesia or anti-anxiety medications.

Inclusion Criteria

My initial diagnosis was either ALL or Lymphoma.
I am currently in the maintenance phase of my treatment.
I have 2 more maintenance treatments left.
See 2 more

Exclusion Criteria

My condition has returned or didn't respond to treatment.
Already does LPs without anesthesia
I have had an ultrasound-guided lumbar puncture before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intrathecal chemotherapy with pain and anxiety management using VR, local anesthesia, and optional anxiolytics during lumbar punctures

Approximately 20 procedures over the course of treatment
20 visits (in-person)

Follow-up

Participants are monitored for feasibility and acceptability of VR as an alternative to general anesthesia

1-3 months

Treatment Details

Interventions

  • Virtual Reality
Trial Overview The study is testing whether using a Virtual Reality headset, along with local anesthesia and optional anti-anxiety medication, can effectively manage pain and anxiety during spinal taps, as an alternative to general anesthesia.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VR ArmExperimental Treatment1 Intervention
Pain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered.
Group II: GA ArmActive Control1 Intervention
Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital.

Virtual Reality is already approved in United States for the following indications:

🇺🇸
Approved in United States as Virtual Reality Therapy for:
  • Functional Dyspepsia
  • Irritable Bowel Syndrome (IBS)
  • Gastroparesis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials
227
Recruited
258,000+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials
6
Recruited
500+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials
6
Recruited
500+

Findings from Research

Virtual reality (VR) interventions have been shown to significantly reduce symptoms of anxiety, depression, pain, and fatigue in cancer patients, based on a meta-analysis of 6 studies.
The findings suggest that while VR is effective for managing acute symptoms during cancer treatment, further research is needed to explore its benefits for long-term side effects in cancer survivorship care.
Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management.Zeng, Y., Zhang, JE., Cheng, ASK., et al.[2020]
The study involving 14 children aged 6 to 18 with acute lymphoblastic leukemia (ALL) demonstrated that virtual reality (VR) technology can effectively reduce perceived pain during L-asparaginase (L-ASP) intramuscular injections, with 8 out of 14 patients reporting less pain after using VR.
Caregivers observed that VR not only improved the children's pain perception but also led to less resistance and crying during the procedure, suggesting that VR can enhance the overall experience of painful treatments in pediatric oncology.
Immersive Virtual Reality to Distract From Pain in Children Treated With L-asparaginase by Intramuscular Injection.Chiu, CC., Lin, YT., Wang, Y., et al.[2023]
A study involving 90 pediatric oncology patients and their caregivers found that an Immersive VR therapeutic intervention was highly acceptable and satisfactory, with minimal adverse effects reported by patients.
Healthcare professionals expressed favorable perceptions of the VR technology, indicating it was easy to use and useful, suggesting strong potential for future implementation in pediatric oncology settings to improve patient quality of life.
Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer.Tennant, M., McGillivray, J., Youssef, GJ., et al.[2021]

References

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]
Immersive Virtual Reality to Distract From Pain in Children Treated With L-asparaginase by Intramuscular Injection. [2023]
Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer. [2021]
Effectiveness of Virtual Reality in Anxiety and Pain Management in Children and Adolescents Receiving Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]
Use of virtual reality in the supportive care management of paediatric patients with cancer. [2021]
Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. [2022]
Impairment of health-related quality of life for children with acute lymphoblastic leukemia over the first year of therapy: A report from the DFCI ALL Consortium. [2023]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Experience in using hydrotherapy in children with acute lymphoblastic leukemia at a sanatorium]. [2007]
Advances of CD19-directed chimeric antigen receptor-modified T cells in refractory/relapsed acute lymphoblastic leukemia. [2023]
Childhood acute lymphocytic leukemia: progress and problems in treatment. [2018]
Unrelated donor allogeneic transplantation for adult acute lymphoblastic leukemia: a review. [2008]
12.United Statespubmed.ncbi.nlm.nih.gov
Novel Therapies in the Treatment of Adult Acute Lymphoblastic Leukemia. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Novel Therapies in Acute Lymphoblastic Leukemia. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Isolated ovarian relapse of pre-B acute lymphoblastic leukemia: a case report. [2009]
15.United Statespubmed.ncbi.nlm.nih.gov
Modern therapy of acute lymphoblastic leukemia. [2022]
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