Effects of Virtual Reality MRI Preparedness
- Conditions
- Educational ProblemsAnxiety
- Interventions
- Device: Pico G2 4k
- Registration Number
- NCT05086263
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Child is between the ages of 8-9 years inclusive
- Child scheduled for a clinical MRI at CHLA.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR Randomization Pico G2 4k 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Successful Imaging without Sedation Up to thirty minutes after intervention A successful image will be produced after MRI. Failure would mean the child is rescheduled for another MRI with sedation.
Faces Pain Scale-Revised (FPS-R) Approximately 5 minutes to one hour before procedure Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.
Child Anxiety Meter State (CAM-S) Approximately 5 minutes to one hour before procedure The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they feel at the moment. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.
Childhood Anxiety Sensitivity Index (CASI) Approximately 5 minutes to one hour before procedure This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.
Visual Analogue Scale (VAS) Approximately 5 minutes to one hour before intervention The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children
Child Anxiety Meter Trait (CAM-T) Approximately 5 minutes to one hour before procedure The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they usually feel at home. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.
- Secondary Outcome Measures
Name Time Method Demographics Up to one hour before intervention 24 Item questionnaire which asks parents demographic questions regarding socioeconomic data.
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States