Effects of Virtual Reality MRI Preparedness

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Educational Problems
• Intervention / Treatment: Device: Pico G2 4k

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Anxiety Sensitivity Index (CASI)	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.	Approximately 5 minutes to one hour before procedure
Number of Participants with Successful Imaging without Sedation	A successful image will be produced after MRI. Failure would mean the child is rescheduled for another MRI with sedation.	Up to thirty minutes after intervention
Visual Analogue Scale (VAS)	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	Approximately 5 minutes to one hour before intervention
Faces Pain Scale-Revised (FPS-R)	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.	Approximately 5 minutes to one hour before procedure
Child Anxiety Meter State (CAM-S)	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.	Approximately 5 minutes to one hour before procedure
Child Anxiety Meter Trait (CAM-T)	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.	Approximately 5 minutes to one hour before procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	24 Item questionnaire which asks parents demographic questions regarding socioeconomic data.	Up to one hour before intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Questionnaire	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.	Immediately after intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: Lumeum Inc.
• Investigators: Principal Investigator: Jeffrey I Gold, PhD, Children's Hospital Los Angeles

Publications and helpful links

General Publications

• Bharti B, Malhi P, Khandelwal N. MRI Customized Play Therapy in Children Reduces the Need for Sedation--A Randomized Controlled Trial. Indian J Pediatr. 2016 Mar;83(3):209-13. doi: 10.1007/s12098-015-1917-x. Epub 2015 Oct 19.
• Carter AJ, Greer ML, Gray SE, Ware RS. Mock MRI: reducing the need for anaesthesia in children. Pediatr Radiol. 2010 Aug;40(8):1368-74. doi: 10.1007/s00247-010-1554-5. Epub 2010 Feb 26.
• Eatough EM, Shirtcliff EA, Hanson JL, Pollak SD. Hormonal reactivity to MRI scanning in adolescents. Psychoneuroendocrinology. 2009 Sep;34(8):1242-6. doi: 10.1016/j.psyneuen.2009.03.006. Epub 2009 Apr 5.
• Power JD, Mitra A, Laumann TO, Snyder AZ, Schlaggar BL, Petersen SE. Methods to detect, characterize, and remove motion artifact in resting state fMRI. Neuroimage. 2014 Jan 1;84:320-41. doi: 10.1016/j.neuroimage.2013.08.048. Epub 2013 Aug 29.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Virtual Reality; Radiology
• Other Study ID Numbers: CHLA-21-00107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No