Virtual Reality for Acute Lymphoblastic Leukemia
(VIRALL Trial)
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?
Is Virtual Reality Therapy safe for humans?
How is Virtual Reality Therapy different from other treatments for acute lymphoblastic leukemia?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intrathecal chemotherapy with pain and anxiety management using VR, local anesthesia, and optional anxiolytics during lumbar punctures
Follow-up
Participants are monitored for feasibility and acceptability of VR as an alternative to general anesthesia
Treatment Details
Interventions
- Virtual Reality
Virtual Reality is already approved in United States for the following indications:
- 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
Rally Foundation for Childhood Cancer Research
Collaborator
Rally Foundation for Childhood Cancer Research
Collaborator