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Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06722638
Acronym
VIRALL
Enrollment
40
Registered
2024-12-09
Start date
2024-08-30
Completion date
2026-12-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Virtual Reality, Lumbar Puncture

Brief summary

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.

Detailed description

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.

Interventions

OTHERUse of Virtual Reality Headset

Virtual Reality Headsets will be used to augment pain and anxiety management during therapeutic LPs in children with acute lymphoblastic leukemia

Sponsors

Rally Foundation for Childhood Cancer Research
CollaboratorOTHER
Children's National Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome: FeasibilityAt time of ProcedureNumber of participants able to receive intrathecal chemotherapy while using Virtual Reality to augment local anesthesia and the option of an anxiolytic for management of pain and anxiety during the lumbar puncture procedure.

Secondary

MeasureTime frameDescription
Secondary Outcome: Acceptability1-3 months after first Lumbar PunctureNumber of participants who, having successfully received intrathecal chemotherapy using Virtual Reality with local anesthesia and the option of an anxiolytic, choose to undergo the next procedrue under the same circumstances.

Countries

United States

Contacts

Primary ContactJennifer Levine, MD
jlevine@childrensnational.org202-476-2140
Backup ContactAlissa Groisser, MD
agroisser@childrensnational.org202-476-2140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026