Actively Recruiting
Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
Led by Children's National Research Institute · Updated on 2024-12-09
40
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
R
Rally Foundation for Childhood Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)
- In maintenance phase of treatment
- Still have 2 maintenance cycles planned
- Aged 7 and over
- Patient able to speak English
- Caregiver able to complete consent and study questionnaires in English or Spanish
You will not qualify if you...
- Relapsed or refractory disease
- Previously required ultrasound guided LP procedure
- Already does LPs without anesthesia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
J
Jennifer Levine, MD
CONTACT
A
Alissa Groisser, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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