Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

NCT06722638 | Recruiting DMC

• 1 other identifier: STUDY00000820
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Virtual Reality; Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Feasibility

  Number 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.

  At time of Procedure

Secondary Outcomes (1)

• Secondary Outcome: Acceptability

  1-3 months after first Lumbar Puncture

Study Arms (2)

VR Arm

EXPERIMENTAL

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.

Other: Use of Virtual Reality Headset

GA Arm

NO INTERVENTION

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.

Interventions

Use of Virtual Reality Headset OTHER

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

VR Arm

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Relapsed or refractory disease
• Previously required ultrasound guided LP procedure
• Already does LPs without anesthesia

Sponsors & Collaborators

• Children's National Research Institute: lead
• Rally Foundation for Childhood Cancer Research: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jennifer Levine, MD

CONTACT

202-476-2140; jlevine@childrensnational.org

Alissa Groisser, MD

CONTACT

202-476-2140; agroisser@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Survivorship and Supportive Care

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: December 9, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available following publication and for the next 5 years.

Locations

US (1)