Clinical trial · Interventional
Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of Virtual Reality Headset | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VR Arm
- description
- 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.
- interventionNames
- Other: Use of Virtual Reality Headset
- type
- NO_INTERVENTION
- label
- GA Arm
- description
- 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.
Primary outcomes (1)
- measure
- Primary Outcome: Feasibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available