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Virtual Reality for Lumbar Puncture Distraction

N/A
Recruiting
Led By James Thomas, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lumbar puncture for chemotherapy per leukemia therapy
Pediatric and young adult patients 10-25 years of age
Must not have
Tested positive for COVID-19, or opted out of of COVID-19 testing
Active nausea or vomiting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Summary

This trial will test whether VR can be used instead of GA for LPs, which are a common but painful medical procedure.

Who is the study for?
This trial is for children and young adults aged 10-25 with leukemia who need a lumbar puncture for chemotherapy. They must have had a previous LP under general anesthesia, be free of COVID-19, not have seizures or severe nausea, and be considered cognitively suitable to use VR.Check my eligibility
What is being tested?
The study is testing if Virtual Reality can replace General Anesthesia as a way to keep patients calm during Lumbar Punctures. It's aimed at seeing if VR can help manage pain and anxiety without the risks associated with anesthesia.See study design
What are the potential side effects?
Virtual Reality may cause discomfort like dizziness or nausea in some individuals. Since it's used instead of General Anesthesia, it avoids potential side effects from those drugs such as allergic reactions or complications from sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving chemotherapy through a lumbar puncture for leukemia.
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I am between 10 and 25 years old.
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I have had a lumbar puncture with general anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tested positive for COVID-19 or chose not to be tested.
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I am currently experiencing nausea or vomiting.
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I have never had a lumbar puncture with general anesthesia.
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I have a history of seizures.
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I am currently experiencing a headache.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success of completion of the LP with VR
Secondary outcome measures
Child Anxiety Meter-State (CAM-S)
Children's Fear Scale (CFS)
Pain Visual Analogue Scale (Pain VAS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VR for LPExperimental Treatment1 Intervention
The patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Patients who agree to undergo an LP with VR will be assessed by a certified child life specialist (CCLS) to determine whether the patient is an appropriate candidate for using VR.The system includes a VR headset with VR software already loaded in to it. The VR software to be used is either a game called "Pebbles the Penguin" or "SpacePups" (Weightless Studios).
Group II: GA for LPActive Control1 Intervention
Patients who decline to undergo an LP with VR will be asked if they would be willing to participate by answering questionnaires specific to their pre procedure anxiety. This will include questionnaires 2 and 3 from above. The investigators will also plan to collect vital sign data if they agree to participate in that capacity.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for leukemia include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but also affects healthy cells, leading to side effects. Targeted therapy focuses on specific molecules involved in cancer cell growth and survival, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These treatments are crucial for leukemia patients as they aim to eliminate cancer cells while preserving as much normal function as possible. In the context of reducing the need for general anesthesia, techniques like Virtual Reality (VR) can be used to manage pain and anxiety during procedures, potentially improving patient comfort and outcomes.
PAIDEIA: pacemaker and implanted cardioverter defibrillator management in radiation therapy-a survey by the Young Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO).Fighting COVID-19.Lessons Learned From a Randomized Controlled Trial of Short-Course Intravenous Antibiotic Therapy for Erysipelas and Cellulitis of the Lower Limb (Switch Trial).

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,240 Total Patients Enrolled
17 Trials studying Leukemia
568 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,381 Total Patients Enrolled
1,518 Trials studying Leukemia
384,692 Patients Enrolled for Leukemia
James Thomas, MDPrincipal InvestigatorPhysician
2 Previous Clinical Trials
195 Total Patients Enrolled

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT04092803 — N/A
Leukemia Research Study Groups: GA for LP, VR for LP
Leukemia Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT04092803 — N/A
Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092803 — N/A
~3 spots leftby Jul 2025