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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,506 Total Patients Enrolled

16 Trials studying Leukemia

557 Patients Enrolled for Leukemia

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,834 Total Patients Enrolled

1,513 Trials studying Leukemia

384,729 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for me to get involved with this research project?

"This trial requires 20 pediatric and young adult patients aged 10-25 with leukemia. Additionally, cognitive capacity must be appropriate according to a child life specialist's assessment, as well as having previously undergone LP with GA."

Answered by AI

How many participants are accepted to this clinical research?

"Absolutely. The latest information accessible via clinicaltrials.gov establishes that this medical study, which was first posted on September 9th 2019, is actively enrolling participants. 20 volunteers are required at 1 particular clinic site for the trial to proceed."

Answered by AI

Is the eligibility for this medical trial confined to persons over 65 years of age?

"The age range of prospective participants in this medical research is 10 to 25 years old. The clinical trial registry shows that 428 trials are available for minors and 1124 studies are open to seniors over 65."

Answered by AI

Are there any open slots for volunteers in this research endeavor?

"Affirmative, the data on clinicaltrials.gov shows that this research trial is actively enrolling participants. It was initially posted in September 2019 and recently updated in August 2022 with a goal of recruiting 20 individuals from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu

2019. "Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092803.

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