The Use of a Mock MRI Scanner for Reducing the Use of Anesthesia in Children Undergoing Clinical MRI Scans

Recruiting in Palo Alto (17 mi)

Overseen byCatherine Lebel, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?

Diagnostic Magnetic Resonance (MR) imaging procedures can be stressful for children and parents. Patients must lie still during the procedure to provide diagnostic quality images. Children \<7 years are often sedated or given general anesthesia (GA) for imaging procedures. The high cost of GA and its associated risks motivate the search for alternatives. The overall goal of this study is to systematically investigate whether training on the mock MR scanner reduces the need for GA during Magnetic Resonance Imaging (MRI) scans in children. 160 participants scheduled for diagnostic MRI scans at Alberta Children's Hospital (ACH) will be recruited to undergo different training methods for MRI scanning. Group 1 will be sent links to online videos about MRI, audio files with scanner noises, and a children's book about MR scans, to prepare at home. Group 2 will receive training materials and visit the ACH to review them with the research team, but will not use the mock scanner. Group 3 will receive training materials and visit the ACH for training on the mock MR scanner. Visits to the mock scanner for Group 3 will include practice lying down, staying still, wearing headphones, and watching a movie on the mirror system. During and after training sessions, the investigators will collect data on total time spent preparing (mock scanner or other), the child's feelings of stress/worry before and after visit, and head motion during mock MRI session (if applicable). Subjects will be scheduled for a clinical scan without GA and a follow-up clinical scan with GA (to be cancelled if the first scan is successful). Scan success will be determined by a radiologist. Measures of scan success, quality ratings for each scan, children's feelings of stress/worry related to the MRI, and saliva samples to measure cortisol and salivary alpha amylase, will be gathered at the clinical scan. An ANOVA will be used to compare different training groups. A clinical group of 35 neuro-oncology patients aged 3-7 years of age that undergo frequent MRI scans will also undergo staged preparation by child life specialists using the mock scanner. The age at which they are able to complete MRI without general anesthesia will be compared with a retrospective control group in the 3 years prior. Measures to be used for this group are the same (with the exception of saliva samples). T test and Kaplan- Meier analysis will be used to compare age at which MRI can be performed awake.

Research Team

Catherine Lebel, PhD

Principal Investigator

catherine.lebel@albertahealthservices.ca

Eligibility Criteria

Inclusion Criteria

Elective MRI scans

No previous Diagnostic MRI without GA

Would normally receive GA for diagnostic MRI

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Treatment Details

Interventions

Child Life Specialist preparation (Behavioural Intervention)
Mock MRI scanner (Behavioural Intervention)
Preparation materials (Behavioural Intervention)
Review Preparation Materials (Behavioural Intervention)

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Group I: Neuro-oncology prospectiveExperimental Treatment2 Interventions

Child life specialist preparation will be provided to these patients. This preparation for Diagnostic MRI scanning in which utilise the Mock MRI scanner as preparation for the scan.

Group II: Group 3: Mock MRI scannerExperimental Treatment2 Interventions

This group will receive the same materials as training group 1. In addition they will attend the mock scanner where the research team will utilise a mock MRI scanner to practice lying down in a scanner, staying still , wearing headphones and watching a movie/video on the mirror system.

Group III: Group 2: Materials with reviewExperimental Treatment2 Interventions

This group will receive in preparation for a clinical MRI scan links to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan. Preparation for this group will occur at home and include a visit with research team to review preparation materials with the research team

Group IV: Group 1: preparation materials onlyExperimental Treatment1 Intervention

This group will receive preparation materials for a clinical MRI scan. These include links to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan. Preparation for this group will occur only at home.

Group V: Neuro-oncology retrospective controlsActive Control1 Intervention

A retrospective control group of neuro-oncology patients from the 3 years prior to the study initiation. This group will be used to determine the age at which patients were able to complete a diagnostic MRI without GA