CompletedNot Applicable

Effects of Virtual Reality MRI Preparedness

United States21 participantsStarted 2022-02-23

Plain-language summary

Magnetic resonance imaging is an important and increasingly prevalent imaging modality used in healthcare. Children often find the procedure anxiety provoking causing difficulty in staying still and providing quality images. The use of preparation techniques including play therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce anxiety and facilitate better image quality. Modalities of preparation including Virtual Reality (VR) pose as an alternative to habituate children for a MRI procedure.

Who can participate

Age range

8 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Child is between the ages of 8-9 years inclusive * Child scheduled for a clinical MRI at CHLA. Exclusion Criteria: * Child is younger than 8 years or older than 9 years. These are the bottom end of age ranges that are frequently sedated. * Children who have metal in their bodies that cannot participant in an MRI. * Medical history that may affect brain development that may confound ability to complete an MRI without sedation. * Children suffering from epilepsy or history of seizures who may react poorly to a virtual reality intervention. * Child who has a history of MRI acquisition where habituation and preparedness may not be needed. * Child with English as a second language due to restrictions of research team. * Child with implantable medical devices or personal medical devices that may be affected by the study device's radio waves

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Childhood Anxiety Sensitivity Index (CASI)

Timeframe: Approximately 5 minutes to one hour before procedure

Number of Participants with Successful Imaging without Sedation

Timeframe: Up to thirty minutes after intervention

Visual Analogue Scale (VAS)

Timeframe: Approximately 5 minutes to one hour before intervention

Faces Pain Scale-Revised (FPS-R)

Timeframe: Approximately 5 minutes to one hour before procedure

Child Anxiety Meter State (CAM-S)

Timeframe: Approximately 5 minutes to one hour before procedure

Child Anxiety Meter Trait (CAM-T)

Timeframe: Approximately 5 minutes to one hour before procedure

Trial details

NCT IDNCT05086263

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-01

View on ClinicalTrials.gov More Anxiety trials

Plain-language summary

Who can participate

Age range

8 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Childhood Anxiety Sensitivity Index (CASI)

Timeframe: Approximately 5 minutes to one hour before procedure

Number of Participants with Successful Imaging without Sedation

Timeframe: Up to thirty minutes after intervention

Visual Analogue Scale (VAS)

Timeframe: Approximately 5 minutes to one hour before intervention

Faces Pain Scale-Revised (FPS-R)

Timeframe: Approximately 5 minutes to one hour before procedure

Child Anxiety Meter State (CAM-S)

Timeframe: Approximately 5 minutes to one hour before procedure

Child Anxiety Meter Trait (CAM-T)

Timeframe: Approximately 5 minutes to one hour before procedure