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

NCT02630342 | Unknown

• 1 other identifier: REB-15-368
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Success of Diagnostic Scan

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

  Immediate: on the date of scheduled MRI

• 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

  3 years

Secondary Outcomes (6)

• Quality of scan Quality of MRI for diagnostic purposes

  Immediate: on the date of scheduled MRI

• Time taken to complete diagnostic MRI

  Immediate: on the date of scheduled MRI

• Number of scan sequences that require repeating

  Immediate: on the date of scheduled MRI

• Childs feelings of stress

  Immediate: on the date of scheduled MRI

• Salivary stress hormone levels (cortisol & alpha amylase)

  Immediate: on the date of scheduled MRI

Study Arms (5)

Group 1: preparation materials only

EXPERIMENTAL

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.

Behavioral: Preparation materials

Group 2: Materials with review

EXPERIMENTAL

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

Behavioral: Preparation materials; Behavioral: Review Preparation Materials

Group 3: Mock MRI scanner

EXPERIMENTAL

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.

Behavioral: Mock MRI scanner; Behavioral: Preparation materials

Neuro-oncology retrospective controls

NO 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

Neuro-oncology prospective

EXPERIMENTAL

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.

Behavioral: Mock MRI scanner; Behavioral: Child Life Specialist preparation

Interventions

Mock MRI scanner BEHAVIORAL

Using a mock scanner for preparation for MRI

Group 3: Mock MRI scanner; Neuro-oncology prospective

Preparation materials BEHAVIORAL

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

Group 1: preparation materials only; Group 2: Materials with review; Group 3: Mock MRI scanner

Child Life Specialist preparation BEHAVIORAL

Child Life Therapist will coordinate the prepartion of the child

Neuro-oncology prospective

Review Preparation Materials BEHAVIORAL

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

Group 2: Materials with review

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Related Publications (10)

• 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.

  PMID: 24096802 BACKGROUND

• 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.

  PMID: 20225122 BACKGROUND

• 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.

  PMID: 22309826 BACKGROUND

• 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.

  PMID: 19684560 BACKGROUND

• 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.

  PMID: 17020606 BACKGROUND

• 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.

  PMID: 20186541 BACKGROUND

• 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.

  PMID: 18084752 BACKGROUND

• 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.

  PMID: 9413970 BACKGROUND

• 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.

  PMID: 16884416 BACKGROUND

• 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.

  PMID: 10142086 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Catherine Lebel, PhD

  catherine.lebel@albertahealthservices.ca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Lebel, PhD

CONTACT

1-403-955-7241; catherine.lebel@albertahealthservices.ca

David R Lardner, MBChB

CONTACT

1-403-955-7810; david.lardner@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Prinicpal Investigator

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)