跳至主要内容
临床试验/NCT02630342
NCT02630342Unknown不适用

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

University of Calgary2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Success of Diagnostic Scan

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Preparation materials (Behavioral)

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

干预措施: Preparation materials (Behavioral)

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

干预措施: Review Preparation Materials (Behavioral)

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.

干预措施: Mock MRI scanner (Behavioral)

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.

干预措施: Preparation materials (Behavioral)

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.

干预措施: Mock MRI scanner (Behavioral)

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.

干预措施: Child Life Specialist preparation (Behavioral)

结局指标

主要结局

Success of Diagnostic Scan

时间窗: 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

时间窗: 3 years

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

次要结局

  • Time taken to complete diagnostic MRI(Immediate: on the date of scheduled MRI)
  • Salivary stress hormone levels (cortisol & alpha amylase)(Immediate: on the date of scheduled MRI)
  • Quality of scan Quality of MRI for diagnostic purposes(Immediate: on the date of scheduled MRI)
  • Childs feelings of stress(Immediate: on the date of scheduled MRI)
  • Compliance with training(2 weeks)
  • Number of scan sequences that require repeating(Immediate: on the date of scheduled MRI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Lardner

Co-Prinicpal Investigator

University of Calgary

研究点 (2)

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