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NCT Number: NCT06722638

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

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.

Recruiting

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

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

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Primary Outcome: Feasibility

    Time frame: At time of Procedure

    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.

Secondary outcomes

  1. Secondary Outcome: Acceptability

    Time frame: 1-3 months after first Lumbar Puncture

    Number 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alissa Groisser, MD

CONTACT

[email protected]

202-476-2140

Jennifer Levine, MD

CONTACT

[email protected]

202-476-2140

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • Rally Foundation for Childhood Cancer Research

Registry information

Acronym: VIRALL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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