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Pico G2 4k for Anxiety

N/A
Waitlist Available
Led By Jeffrey I Gold, PhD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 minutes to one hour before intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial uses Virtual Reality (VR) to help children feel less anxious about MRI scans. By simulating the procedure beforehand, children become more comfortable and can stay still, leading to better image quality. VR has been shown to reduce anxiety in children during various medical procedures.

Eligible Conditions
  • Anxiety
  • Learning Difficulties

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 minutes to one hour before procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 minutes to one hour before procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child Anxiety Meter State (CAM-S)
Child Anxiety Meter Trait (CAM-T)
Childhood Anxiety Sensitivity Index (CASI)
+3 more
Secondary study objectives
Demographics
Other study objectives
Satisfaction Questionnaire

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 RandomizationExperimental Treatment1 Intervention
The virtual reality MRI training will be conducted immediately after completion of the questionnaires in a distraction free room. The training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Using audio/visual cues and biofeedback training is aimed to mimic the experience of the MRI with real audio recordings of image acquisition, in order to adequately train the view to stay still in an MRI procedure. The research subject will continue with their regularly scheduled MRI. The modified Yale Preoperative Anxiety Scale (mYPAS) is an observational measure and will be completed by research staff.
Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention
Participants would take the same questionnaires as the VR interventional group except the RT questionnaire. Then they will proceed with their MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pico G2 4k
2022
N/A
~30

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
246 Previous Clinical Trials
5,073,321 Total Patients Enrolled
8 Trials studying Anxiety
2,710 Patients Enrolled for Anxiety
Lumeum Inc.UNKNOWN
Jeffrey I Gold, PhDPrincipal InvestigatorChildren's Hospital Los Angeles
3 Previous Clinical Trials
1,257 Total Patients Enrolled
2 Trials studying Anxiety
1,150 Patients Enrolled for Anxiety

Media Library

Pico G2 4k Clinical Trial Eligibility Overview. Trial Name: NCT05086263 — N/A
Pico G2 4k 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086263 — N/A
Anxiety Research Study Groups: Standard of Care (No VR) Randomization, VR Randomization
Anxiety Clinical Trial 2023: Pico G2 4k Highlights & Side Effects. Trial Name: NCT05086263 — N/A
~6 spots leftby Nov 2025