Effects of Virtual Reality MRI Preparedness

Anxiety Clinical Trial

Official title:

Effects of Virtual Reality MRI Preparedness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086263
• Other study ID #: CHLA-21-00107
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Educational Problems

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Demographics	24 Item questionnaire which asks parents demographic questions regarding socioeconomic data.	Up to one hour before intervention

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