Recruiting

Mock MRI

Sponsor:

University of Calgary

Code:

NCT02630342

Conditions

Magnetic Resonance Imaging

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Interventions

Mock MRI scanner

Preparation materials

Child Life Specialist preparation

Review Preparation Materials

Study Details

Brief 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

Study ID

NCT02630342

Start date

Jan, 2016

Status verified date

May, 2019

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Elective MRI scans
  • No previous Diagnostic MRI without GA
  • Would normally receive GA for diagnostic MRI
  • No significant developmental delay
  • Ability to understand English for groups 1,2 and 3.
  • For neuro-oncology group: Ability of accompanying parent and/or child to communicate in English with regular exposure of the child to the English language
  • For Neuro-oncology subgroup:a diagnosis of primary brain tumor under the care of neuro-oncology at Alberta Children's Hospital

Exclusion Criteria:

  • Inability to understand consent form
  • Urgent Scans (insufficient time to prepare)
  • Previous diagnostic MRI without the need for general anesthesia
  • Fast brain MRI (single sequence for sole purpose of determining size of cerebrospinal fluid (CSF) spaces)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1: preparation materials only

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.

experimental: Group 2: Materials with review

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

experimental: Group 3: Mock MRI scanner

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.

no intervention: Neuro-oncology retrospective controls

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

experimental: Neuro-oncology prospective

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.

Interventions

Mock MRI scanner

Using a mock scanner for preparation for MRI

Preparation materials

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

Child Life Specialist preparation

Child Life Therapist will coordinate the prepartion of the child

Review Preparation Materials

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

Primary outcome measure

  • Success of Diagnostic Scan [ Time Frame: Immediate: on the date of scheduled MRI ]
  • Neuro-oncology Age of completion of MRI without GA [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

More Information

Sponsor

University of Calgary

Last update posted

May 30, 2019

Last verified

May, 2019

Keywords

  • Mock Scanner
  • Child Life Specialist
  • Patient Preparation
  • Child, Preschool
  • Child
  • Anxiety
  • Human
  • Anesthesia, General

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2019-05-30.