Clinical trial NCT05086263: Effects of Virtual Reality MRI Preparedness
Official title: Effects of Virtual Reality MRI Preparedness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Educational Problems
Keywords: Virtual Reality
Magnetic resonance imaging
Radiology
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Number of Participants with Successful Imaging without Sedation
timeFrame: Up to thirty minutes after intervention
measure: Visual Analogue Scale (VAS)
timeFrame: Approximately 5 minutes to one hour before intervention
measure: Faces Pain Scale-Revised (FPS-R)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Child Anxiety Meter State (CAM-S)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Child Anxiety Meter Trait (CAM-T)
timeFrame: Approximately 5 minutes to one hour before procedure
Secondary outcomes:
measure: Demographics
timeFrame: Up to one hour before intervention
Other outcomes:
measure: Satisfaction Questionnaire
timeFrame: Immediately after intervention
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jeffrey I Gold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.