Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 7 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Spinal tap (lumbar puncture)
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether virtual reality through a headset can help manage pain and worry during spinal taps instead of medicine that puts patients to sleep. It uses medicine to numb the area, with the option of medicine for anxiety. The study is for patients age 7 and older with acute lymphoblastic leukemia (ALL) or lymphoma who are in the maintenance phase of treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have an initial diagnosis of ALL or lymphoma, two types of cancer.
- Be in the maintenance phase of treatment.
- Have at least 2 maintenance treatment cycles still planned.
- Be age 7 or older.
- Be able to speak English.
- Have a caregiver who can complete consent forms and study surveys in English or Spanish.
Who can't join
- Cancer has come back or has not responded to treatment.
- Have needed ultrasound imaging to guide a spinal tap in the past.
- Already have spinal taps without anesthesia, medicine that numbs pain or puts you to sleep.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
DC
- Children's National Hospital · Washington D.C., DC 20010More trials in Washington D.C.