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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.