Recruiting

Virtual Reality

Sponsor:

Children's National Research Institute

Code:

NCT06722638

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Use of Virtual Reality Headset

Study Details

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

Study ID

NCT06722638

Start date

Aug 30, 2024

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: VR Arm

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.

no intervention: GA Arm

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

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

Primary outcome measure

  • Primary Outcome: Feasibility [ Time Frame: At time of Procedure ]

Central Contacts and Locations

Central contacts

Jennifer Levine, MD

202-476-2140jlevine@childrensnational.org

Alissa Groisser, MD

202-476-2140agroisser@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

More Information

Sponsor

Children's National Research Institute

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Keywords

  • Virtual Reality
  • Lumbar Puncture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2024-12-09.