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

NCT02630342 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-05-30

No results posted yet for this study

Summary

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.

Conditions

  • Magnetic Resonance Imaging

Interventions

BEHAVIORAL

Mock MRI scanner

Using a mock scanner for preparation for MRI

BEHAVIORAL

Preparation materials

links to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan.

BEHAVIORAL

Child Life Specialist preparation

Child Life Therapist will coordinate the prepartion of the child

BEHAVIORAL

Review Preparation Materials

Review of preparation materials at the hospital with member of research team

Sponsors & Collaborators

  • Alberta Children's Hospital

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630342 on ClinicalTrials.gov