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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 minutes to one hour before procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 minutes to one hour before procedure
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 moreSecondary 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
247 Previous Clinical Trials
5,073,343 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Children who have epilepsy or a history of seizures that could have a negative reaction to the virtual reality treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (No VR) Randomization
- Group 2: VR Randomization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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