← Back to Search

Behavioural Intervention

Virtual Reality for Acute Lymphoblastic Leukemia (VIRALL Trial)

N/A

Recruiting

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)

Still have 2 maintenance cycles planned

Must not have

Relapsed or refractory disease

Previously required ultrasound guided LP procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-3 months after first lumbar puncture

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find a way to reduce the use of general anesthesia in children and adolescents receiving chemotherapy for acute lymphoblastic leukemia. The researchers will test if using virtual reality, along with local anesthesia

Who is the study for?

This trial is for children and adolescents over 7 years old with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of treatment. They must be scheduled to receive spinal taps as part of their therapy but cannot participate if they have conditions that make VR use unsafe or have had previous adverse reactions to local anesthesia or anti-anxiety medications.

What is being tested?

The study is testing whether using a Virtual Reality headset, along with local anesthesia and optional anti-anxiety medication, can effectively manage pain and anxiety during spinal taps, as an alternative to general anesthesia.

What are the potential side effects?

Potential side effects may include discomfort from wearing the VR headset, dizziness or nausea related to virtual reality exposure, and typical risks associated with local anesthesia such as localized pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My initial diagnosis was either ALL or Lymphoma.

Select...

I have 2 more maintenance treatments left.

Select...

I am 7 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition has returned or didn't respond to treatment.

Select...

I have had an ultrasound-guided lumbar puncture before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-3 months after first lumbar puncture

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-3 months after first lumbar puncture

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 months after first lumbar puncture for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

: Feasibility

Secondary study objectives

: Acceptability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR ArmExperimental Treatment1 Intervention

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.

Group II: GA ArmActive Control1 Intervention

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.

0 / 5Eligibility criteria met