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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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:
- Determine whether pre-scan training allows children to have successful diagnostic MRI scans without general anesthesia.
- Examine the effects of different types of pre-scan training on reducing anxiety and stress in children and their parents related to diagnostic MRI.
- 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:
- Study number
- Sex
- Age at time of scan(s)
- Type of diagnostic scans requested
- Parent report on overall stress
- Parent proxy measures of child stress/worry (PedsQL)
- Parent predictions of child success on MRI
- (Aim 3 only) Primary Oncology Diagnosis: i) Site ii) Histology
- (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:
- Total time spent preparing (mock scanner or other)
- Child's feelings of stress/worry before and after visit (PedsQL)
- Head motion during mock MRI session (if applicable)
Diagnostic MRI Sessions
The following information will be recorded for each child's MRI scan:
- Date of MRI.
- Child's age at time of scanning.
- Scan success without anesthesia (pass/fail)
- Number of sequences requiring repeating
- Total scan length (mins)
- Sum of individual scan sequence times (mins)
- 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)
- Parent proxy measures of child stress ( PedsQL )
- Child's stress/worry (PedsQL)
- (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.
- Conditions
- Magnetic Resonance Imaging
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. 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.
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
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)
Quality of scan Quality of MRI for diagnostic purposes
Ability to use scan for diagnostic purpose
Measured: Immediate: on the date of scheduled MRI
Time taken to complete diagnostic MRI
Time in minutes
Measured: Immediate: on the date of scheduled MRI
Number of scan sequences that require repeating
Number of scans sequences that need repeating
Measured: Immediate: on the date of scheduled MRI
Childs feelings of stress
Using Peds QL child version and parent proxy version to quantify stress
Measured: Immediate: on the date of scheduled MRI
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
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.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital
- Responsible party
- Principal investigator, David Lardner, University of Calgary
- Investigators
- Catherine Lebel, PhD, Principal investigator, catherine.lebel@albertahealthservices.ca
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 24096802de 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 20225122Lueken 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 22309826Raschle 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 19684560Sherman 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 17020606Carter 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 20186541Hallowell 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 18084752Pressdee 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 9413970de 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 16884416Tyc 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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Mock MRI Scanner for Reducing the Use of Anesthesia in Children Undergoing Clinical MRI Scans
- ClinicalTrials.gov ID
- NCT02630342
- Acronym / sponsor ID
- REB-15-368
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Mock Scanner, Child Life Specialist, Patient Preparation, Child, Preschool, Child, Anxiety, Human, Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital
- Study start
- Jan 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Determine whether pre-scan training allows children to have successful diagnostic MRI scans without general anesthesia.
- Examine the effects of different types of pre-scan training on reducing anxiety and stress in children and their parents related to diagnostic MRI.
- 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:
- Study number
- Sex
- Age at time of scan(s)
- Type of diagnostic scans requested
- Parent report on overall stress
- Parent proxy measures of child stress/worry (PedsQL)
- Parent predictions of child success on MRI
- (Aim 3 only) Primary Oncology Diagnosis: i) Site ii) Histology
- (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:
- Total time spent preparing (mock scanner or other)
- Child's feelings of stress/worry before and after visit (PedsQL)
- Head motion during mock MRI session (if applicable)
Diagnostic MRI Sessions
The following information will be recorded for each child's MRI scan:
- Date of MRI.
- Child's age at time of scanning.
- Scan success without anesthesia (pass/fail)
- Number of sequences requiring repeating
- Total scan length (mins)
- Sum of individual scan sequence times (mins)
- 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)
- Parent proxy measures of child stress ( PedsQL )
- Child's stress/worry (PedsQL)
- (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: preparation materials only | Experimental | Behavioral: Preparation materialsThis 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 2: Materials with review | Experimental | Behavioral: Preparation materials, Behavioral: Review Preparation MaterialsThis 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 3: Mock MRI scanner | Experimental | Behavioral: Mock MRI scanner, Behavioral: Preparation materialsThis 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. |
| 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 | Behavioral: Mock MRI scanner, Behavioral: Child Life Specialist preparationChild 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mock MRI scannerUsing a mock scanner for preparation for MRI | Behavioural | Group 3: Mock MRI scanner, Neuro-oncology prospective |
| Preparation materialslinks to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan. | Behavioural | Group 1: preparation materials only, Group 2: Materials with review, Group 3: Mock MRI scanner |
| Child Life Specialist preparationChild Life Therapist will coordinate the prepartion of the child | Behavioural | Neuro-oncology prospective |
| Review Preparation MaterialsReview of preparation materials at the hospital with member of research team | Behavioural | Group 2: Materials with review |
Primary outcome
Success of Diagnostic Scan
Time frame: Immediate: on the date of scheduled MRI
Whether child is able to complete a diagnostic MRI scan without general anesthesia
Neuro-oncology Age of completion of MRI without GA
Time frame: 3 years
Determine the age at which neuro-oncology patients can complete a full diagnostic MRI without requiring general anesthesia
6 secondary outcomes
Quality of scan Quality of MRI for diagnostic purposes
Time frame: Immediate: on the date of scheduled MRI
Time taken to complete diagnostic MRI
Time frame: Immediate: on the date of scheduled MRI
Number of scan sequences that require repeating
Time frame: Immediate: on the date of scheduled MRI
Childs feelings of stress
Time frame: Immediate: on the date of scheduled MRI
Salivary stress hormone levels (cortisol & alpha amylase)
Time frame: Immediate: on the date of scheduled MRI
Compliance with training
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Background: PubMed 24096802Barnea-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.
- Background: PubMed 20225122de 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Lebel, PhD principal investigator
catherine.lebel@albertahealthservices.ca
1 site in 1 country: see every site and its status.
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.