About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Relapsed or refractory disease
Previously required ultrasound guided LP procedure
Already does LPs without anesthesia
Trial design
Parallel
Treatments tested in this trial
Use of Virtual Reality Headset
Other interventionVirtual Reality Headsets will be used to augment pain and anxiety management during therapeutic LPs in children with acute lymphoblastic leukemia
Treatment groups
Trial outcomes
Primary outcomes
Primary Outcome: Feasibility
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
Secondary Outcome: Acceptability
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.
Sponsors and contacts
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Children's National Research Institute
Lead sponsor
Rally Foundation for Childhood Cancer Research
Collaborator