Effects of Virtual Reality MRI Preparedness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2023-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Educational Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A schedule of randomization matching and stratified in age and gender will be computer generated and used to determine which group the child will be placed in. Neither the investigator nor child will know which group they are in until after the parent and child complete the first set of questionnaires

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Standard of Care (No VR) Randomization

Participants would take the same questionnaires as the VR interventional group except the RT questionnaire. Then they will proceed with their MRI.

Group Type NO_INTERVENTION

No interventions assigned to this group

VR Randomization

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 Type EXPERIMENTAL

Pico G2 4k

Intervention Type DEVICE

On this virtual reality headset, it will be loaded with an educational virtual reality mock MRI training titled "Ready Teddy". This training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Furthermore, using audio/visual cues, when the viewer moves their head too much in a MRI like setting they are reminded to stay still. 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.

Interventions

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Pico G2 4k

On this virtual reality headset, it will be loaded with an educational virtual reality mock MRI training titled "Ready Teddy". This training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Furthermore, using audio/visual cues, when the viewer moves their head too much in a MRI like setting they are reminded to stay still. 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes