TrialPath
← Back to searchRecruiting

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

NCT06722638 · Children's National Research Institute
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will be long-term survivors. To help prevent disease recurrence in the central nervous system, patients receive intrathecal chemotherapy, delivered via lumbar puncture, at least 20 times over the course of treatment. Although critical for cure, this component of treatment is a risk factor for neurocognitive impairments that can subsequently affect the daily living skills and academic achievement of survivors. It is now understood that the general anesthesia used to manage pain and anxiety during lumbar punctures also contributes to impairments in neurocognitive functioning. Recent studies have demonstrated that the use of general anesthesia can be decreased by using local anesthesia and offering oral or IV anxiolytic medications. The investigators propose that adding virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), to local anesthesia and the option for anxiolytics will be superior to using those medications alone. The investigators' aim in this study is to demonstrate the feasibility of using VR, in conjunction with local anesthesia and oral/IV anti-anxiety medications, in participants 7 years of age and older with ALL in the maintenance phase of treatment. The multi-disciplinary investigator team, which includes experts in pediatric oncology, survivorship, patient reported outcomes, VR technology and VR content, is uniquely suited to successfully develop, implement, and evaluate this strategy. The investigators' long-term objective is to create a scalable and sustainable alternative to general anesthesia that will adequately manage pain and anxiety without compromising neurocognitive function. By systematically working towards this long-term objective, the investigators seek to help survivors of childhood cancer lead happy, normal lives, free from acquired neurocognitive impairment.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Relapsed or refractory disease * Previously required ultrasound guided LP procedure * Already does LPs without anesthesia
Study design
Enrollment target: 40 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-08-30
Estimated completion: 2026-12
Last updated: 2024-12-09
Interventions
Other: Use of Virtual Reality Headset
Primary outcomes
  • Primary Outcome: Feasibility (At time of Procedure)
Sponsor
Children's National Research Institute · other
With: Rally Foundation for Childhood Cancer Research
Contacts & investigators
ContactJennifer Levine, MD · contact · jlevine@childrensnational.org · 202-476-2140
ContactAlissa Groisser, MD · contact · agroisser@childrensnational.org · 202-476-2140
All locations (1)
Children's National HospitalRecruiting
Washington D.C., District of Columbia, United States
Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia · TrialPath