Anxiety, Educational Problems
Conditions
Keywords
Virtual Reality, Magnetic resonance imaging, Radiology
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.
Interventions
DEVICEPico 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.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
8 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Up to one hour before intervention | 24 Item questionnaire which asks parents demographic questions regarding socioeconomic data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Questionnaire | Immediately after intervention | 45 item questionnaire using a four point scale (strongly agree, agree, disagree, and strongly disagree) to gauge ease of use and satisfaction using the VR headset. Higher scores reflect greater satisfaction. |
Countries
United States
Outcome results
None listed