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NCT06722638Recruiting

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
2 Jul 2024
Start date
30 Aug 2024
Primary completion date
Jul 2026
Lead sponsor
Children's National Research Institute
NCT number
NCT06722638

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 30 Aug 2024 to the primary completion date, Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously required ultrasound guided LP procedure

Other illness

  • Relapsed or refractory disease

Other

  • Already does LPs without anesthesia

Who the study is looking for

  • 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

Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Children's National Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.