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Magnetic Resonance ImagingNCT02630342

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

A study testing Mock MRI scanner, Preparation materials and Child Life Specialist preparation in people with Magnetic Resonance Imaging, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Magnetic Resonance Imaging
What is being tested?
Mock MRI scanner, Preparation materials and Child Life Specialist preparation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteCanada
Study dates
Jan 2016to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Catherine Lebel, PhD, 1-403-955-7241, catherine.lebel@albertahealthservices.ca

    David R Lardner, MBChB, 1-403-955-7810 ext. 52375, david.lardner@albertahealthservices.ca

    Recruiting

Other trials in Canada

About this study

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).

Read more

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.

Read the detailed description

Diagnostic MR procedures can be scary and stressful for children and parents. Because patients must lie still during the procedure to provide diagnostic quality images, young children (typically <7 years) and others not expected to comply are often sedated or given general anesthesia (GA) for imaging procedures. However, the high cost of GA and its associated risks motivate the search for alternatives. Previous reports demonstrate that preparation (including using a mock MR scanner) reduces anxiety and increases compliance for clinical and research MRI procedures without GA. However, systematic studies of the advantages of a mock MR scanner versus other training methods are lacking. Furthermore, while reducing the use of GA is desirable, repeated unsuccessful scanning procedures are also costly, so identifying factors that predict success for diagnostic MR procedures is important to effectively allocate resources.

Aims

The overall goal of this study is to systematically investigate whether training on the mock MR scanner reduces the need for GA during MRI scans in children. There are three specific aims:

  1. Determine whether pre-scan training allows children to have successful diagnostic MRI scans without general anesthesia.
  2. Examine the effects of different types of pre-scan training on reducing anxiety and stress in children and their parents related to diagnostic MRI.
  3. Determine whether mock scanner training can lower the age at which neuro-oncology patients are able to complete a full diagnostic MRI without anesthesia compared with historic controls.

Patient name, date of birth, and hospital identification number are necessary to perform chart review and access diagnostic images. All identifying information will be removed prior to data analysis.

The following data will be collected/recorded for each participant at enrollment:

  1. Study number
  2. Sex
  3. Age at time of scan(s)
  4. Type of diagnostic scans requested
  5. Parent report on overall stress
  6. Parent proxy measures of child stress/worry (PedsQL)
  7. Parent predictions of child success on MRI
  8. (Aim 3 only) Primary Oncology Diagnosis: i) Site ii) Histology
  9. (Aim 3 only) Treatment mode i) Surgery ii) Chemotherapy iii) Radiotherapy

Training Sessions

For Aims 1 and 2, participants will be randomly assigned to one of three training groups. 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. The Child Life Specialist will talk with the child and his/her family about the experience, and allow them up to 1 hour of practice time on the mock scanner.

For Aim 3, all participants will receive training on the mock scanner similar to group 3 with the difference being Child Life Specialists will utilize a goal based preparation of 3 X 20 minute sessions to coincide with other visits to the hospital.

All participants will be booked for one MR scan without GA and one with GA a week later in case the first scan fails.

The following data will be collected during/after training sessions:

  1. Total time spent preparing (mock scanner or other)
  2. Child's feelings of stress/worry before and after visit (PedsQL)
  3. Head motion during mock MRI session (if applicable)

Diagnostic MRI Sessions

The following information will be recorded for each child's MRI scan:

  1. Date of MRI.
  2. Child's age at time of scanning.
  3. Scan success without anesthesia (pass/fail)
  4. Number of sequences requiring repeating
  5. Total scan length (mins)
  6. Sum of individual scan sequence times (mins)
  7. Quality of images, as determined by a pediatric neuro-radiologist and graded as Excellent (no motion artifact ), Good (minimal motion artifact ); Acceptable (motion artifact; but satisfactory to answer the clinical question); Unacceptable (significant motion artifact ; unable to answer the clinical question)
  8. Parent proxy measures of child stress ( PedsQL )
  9. Child's stress/worry (PedsQL)
  10. (Aims 1 and 2) Saliva sample to measure cortical and salivary alpha amylase before and after diagnostic MR scan

If images are deemed suitable for clinical diagnosis, the subsequent GA booking will be cancelled.

No raw images will be retained for any patients outside of their hospital record.

For Aim 3 prospective data, the above information will be recorded at each scanning session until the patient is able to complete the entire scan without anesthesia.

For Aim 3 retrospective data: The patient's hospital identification number will be used to identify MRI scans performed on that patient in the 3 years prior to the study. The MRI report will be cross referenced with the department of anesthesia electronic database to determine the date and thereby the age at which MRI without GA was able to be performed. In the case where the MRI report states that scan was performed under GA but no electronic record of GA is present the paper chart will be reviewed to determine if GA was performed. If The MRI scan report does not specify that GA was performed and an anesthesia record for the MRI exists then scan will be considered to have been performed under GA.

Statistical Plan

An ANOVA will be used to evaluate group differences on scanning success measures. Additional analyses will focus on correlations between scan successes and age, sex, measures of child/parent stress, cortisone, salivary alpha amylase, and training session compliance.

Aim 3 will also explicitly test differences in the mean age in months at which neuro-oncology patients were able to successfully complete the diagnostic MRI without anesthesia in the groups with and without mock scanner training. These will be compared utilizing T-test and Kaplan-Meier Analysis.

Being tested
Mock MRI scanner, Preparation materials, Child Life Specialist preparation, Review Preparation Materials
Keywords
Mock Scanner, Child Life Specialist, Patient Preparation, Child, Preschool, Child, Anxiety, Human, Anesthesia, General
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mock MRI scannerBehavioural

    Using a mock scanner for preparation for MRI

  • Preparation materialsBehavioural

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

  • Child Life Specialist preparationBehavioural

    Child Life Therapist will coordinate the prepartion of the child

  • Review Preparation MaterialsBehavioural

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

Study groups in NCT02630342
Study groupRoleWhat they receive
Group 1: preparation materials onlyExperimentalThis 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.
Receives: Behavioral: Preparation materials
Group 2: Materials with reviewExperimentalThis 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
Receives: Behavioral: Preparation materials; Behavioral: Review Preparation Materials
Group 3: Mock MRI scannerExperimentalThis 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.
Receives: Behavioral: Mock MRI scanner; Behavioral: Preparation materials
Neuro-oncology retrospective controlsNo interventionA 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
Neuro-oncology prospectiveExperimentalChild 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.
Receives: Behavioral: Mock MRI scanner; Behavioral: Child Life Specialist preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of Diagnostic Scan

    Whether child is able to complete a diagnostic MRI scan without general anesthesia

    Measured: Immediate: on the date of scheduled MRI

  2. Neuro-oncology Age of completion of MRI without GA

    Determine the age at which neuro-oncology patients can complete a full diagnostic MRI without requiring general anesthesia

    Measured: 3 years

Secondary outcomes (6)
  1. Quality of scan Quality of MRI for diagnostic purposes

    Ability to use scan for diagnostic purpose

    Measured: Immediate: on the date of scheduled MRI

  2. Time taken to complete diagnostic MRI

    Time in minutes

    Measured: Immediate: on the date of scheduled MRI

  3. Number of scan sequences that require repeating

    Number of scans sequences that need repeating

    Measured: Immediate: on the date of scheduled MRI

  4. Childs feelings of stress

    Using Peds QL child version and parent proxy version to quantify stress

    Measured: Immediate: on the date of scheduled MRI

  5. Salivary stress hormone levels (cortisol & alpha amylase)

    Salivary stress hormones will be measured for training groups 1,2 and 3

    Measured: Immediate: on the date of scheduled MRI

  6. Compliance with training

    recording the amount of time preparation took

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630342
Sponsor's protocol ID
REB-15-368
Status last verified
May 2019
First submitted
9 Dec 2015
Last updated
30 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Barnea-Goraly N, Weinzimer SA, Ruedy KJ, Mauras N, Beck RW, Marzelli MJ, Mazaika PK, Aye T, White NH, Tsalikian E, Fox L, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). High success rates of sedation-free brain MRI scanning in young children using simple subject preparation protocols with and without a commercial mock scanner--the Diabetes Research in Children Network (DirecNet) experience. Pediatr Radiol. 2014 Feb;44(2):181-6. doi: 10.1007/s00247-013-2798-7. Epub 2013 Oct 6.

    PubMed 24096802
  • de Bie HM, Boersma M, Wattjes MP, Adriaanse S, Vermeulen RJ, Oostrom KJ, Huisman J, Veltman DJ, Delemarre-Van de Waal HA. Preparing children with a mock scanner training protocol results in high quality structural and functional MRI scans. Eur J Pediatr. 2010 Sep;169(9):1079-85. doi: 10.1007/s00431-010-1181-z. Epub 2010 Mar 13.

    PubMed 20225122
  • Lueken U, Muehlhan M, Evens R, Wittchen HU, Kirschbaum C. Within and between session changes in subjective and neuroendocrine stress parameters during magnetic resonance imaging: A controlled scanner training study. Psychoneuroendocrinology. 2012 Aug;37(8):1299-308. doi: 10.1016/j.psyneuen.2012.01.003. Epub 2012 Feb 5.

    PubMed 22309826
  • Raschle NM, Lee M, Buechler R, Christodoulou JA, Chang M, Vakil M, Stering PL, Gaab N. Making MR imaging child's play - pediatric neuroimaging protocol, guidelines and procedure. J Vis Exp. 2009 Jul 30;(29):1309. doi: 10.3791/1309.

    PubMed 19684560
  • Sherman SA, Eisen S, Burwinkle TM, Varni JW. The PedsQL Present Functioning Visual Analogue Scales: preliminary reliability and validity. Health Qual Life Outcomes. 2006 Oct 4;4:75. doi: 10.1186/1477-7525-4-75.

    PubMed 17020606
  • 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.

    PubMed 20186541
  • Hallowell LM, Stewart SE, de Amorim E Silva CT, Ditchfield MR. Reviewing the process of preparing children for MRI. Pediatr Radiol. 2008 Mar;38(3):271-9. doi: 10.1007/s00247-007-0704-x. Epub 2007 Dec 15.

    PubMed 18084752
  • Pressdee D, May L, Eastman E, Grier D. The use of play therapy in the preparation of children undergoing MR imaging. Clin Radiol. 1997 Dec;52(12):945-7. doi: 10.1016/s0009-9260(97)80229-2.

    PubMed 9413970
  • de Amorim e Silva CJ, Mackenzie A, Hallowell LM, Stewart SE, Ditchfield MR. Practice MRI: reducing the need for sedation and general anaesthesia in children undergoing MRI. Australas Radiol. 2006 Aug;50(4):319-23. doi: 10.1111/j.1440-1673.2006.01590.x.

    PubMed 16884416
  • Tyc VL, Fairclough D, Fletcher B, Leigh L, Mulhern RK. Children's distress during magnetic resonance imaging procedures. Child Health Care. 1995 Winter;24(1):5-19. doi: 10.1207/s15326888chc2401_2.

    PubMed 10142086

Questions about this trial

What is this clinical trial studying?

A study testing Mock MRI scanner, Preparation materials and Child Life Specialist preparation in people with Magnetic Resonance Imaging, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Catherine Lebel, PhD (1-403-955-7241, catherine.lebel@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of Diagnostic Scan (time frame: Immediate: on the date of scheduled MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02630342, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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