RECRUITING

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Quick Facts

Study Start:2024-08-30
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06722638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)
  2. * In maintenance phase of treatment
  3. * Still have 2 maintenance cycles planned
  4. * Aged 7 and over
  5. * Patient able to speak English
  6. * Caregiver able to complete consent and study questionnaires in English or Spanish
  1. * Relapsed or refractory disease
  2. * Previously required ultrasound guided LP procedure
  3. * Already does LPs without anesthesia

Contacts and Locations

Study Contact

Jennifer Levine, MD
CONTACT
202-476-2140
jlevine@childrensnational.org
Alissa Groisser, MD
CONTACT
202-476-2140
agroisser@childrensnational.org

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-30
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • Lumbar Puncture

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia, Pediatric