LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety. (LEGO MRI)

The objective of the LEGO®Bricks MRI project is to study a new play-based tool for use in children preparing to undergo MRI and evaluate its ability to reduce the need for anesthesia.

A randomized study design will be employed in the experimental "Child Life" (CL) group, in regard to which Child Life intervention patients will have. Age matched controls will be found retrospectively, and will be patients of the same age, undergoing their first non-contrast brain MRI with no Child Life intervention.

Patients in the CL group will be prepped by a Certified Child Life Specialist with the use of one of the following 2 tools, to be randomly selected:

1. LEGO Bricks model MRI (A model of the MRI machine and adjacent control room made out of LEGO bricks)
2. Mock MRI tube (A six foot long pop-out play tunnel for children, with a diameter of around 17 inches to simulate the MRI magnet bore)

Study Overview

• Status: Withdrawn
• Conditions: MRI; Stress; Anxiety; Anesthesia; Sedation; Children, Only
• Intervention / Treatment: Other: LEGO Bricks MRI; Other: Mock MRI tube

Detailed Description

Diagnostic imaging is frequently utilized in modern medical practice, and various imaging modalities are routinely utilized in the care of pediatric patients. Magnetic resonance imaging (MRI) is an advanced imaging modality that is utilized to evaluate many conditions in pediatric patients. MRI is frequently favored over other imaging modalities in pediatrics since it allows for high-quality cross sectional imaging without the use of potentially harmful ionizing radiation, to which children are more sensitive than adults. However, MRI quality is highly dependent on patients' ability to hold still and follow instructions, which is often challenging in pediatric patients. Young and uncooperative children often require anesthesia to successfully complete MRI. Anesthesia can often be avoided with the assistance of Certified Child Life Specialists, who use techniques to reduce patient anxiety and improve children's ability to follow instructions during MRI. For example, children may visit the MRI unit or a simulator prior to the examination to contextualize the procedure1-3. Preparation, in the form of play, has been proven to reduce anxiety in children prior to scans and invasive medical procedures. Children who are prepared for medical procedures experience less fear and anxiety and will have better long term adjustment to medical challenges (Koller, 2008).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 4 and 10 years of age
• Undergoing first MRI
• MRI brain without contrast

Exclusion Criteria:

• Diagnosed serious illness/mental disability
• Have undergone prior MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Child life group with LEGO bricks; Patients in this group will be prepped by a Certified Child Life Specialist with the use of LEGO bricks model MR	Other: LEGO Bricks MRI; LEGO Bricks model MRI (A model of the MRI machine and adjacent control room made out of LEGO bricks) will be used by the child life specialist to prepare the child for MRI
No Intervention: Control group; Age matched controls will be found retrospectively, and will be patients of the same age, undergoing their first non-contrast brain MRI with no Child Life intervention.
Experimental: Child life group with Mock MRI tube; Patients in this group will be prepped by a Certified Child Life Specialist with the use of a Mock MRI tube	Other: Mock MRI tube; Mock MRI tube will be used by the child life specialist to prepare the child for MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who need anesthesia - Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group	Monitor whether or not the child needs anesthesia to successfully complete MRI exam	Up to 90 minutes (duration of MRI exam)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Scores -Comparing CL groups (1) LEGO Bricks model MRI and (2) mock MRI tube -- Control group will not have Anxiety Scores available, and will not be assessed on this secondary outcome measure.	Anxiety score will be measured by response to a series of questions using an anxiety self rating scale where for each questions particpants need to decide if Not at all applies (mark 1) Somewhat (mark 2) Moderately (mark 3) Very much (mark 4).	At time of enrollment (Baseline) and at the end of MRI exam, which typically ranges from 15-90 minutes
Change in quality of MRI image- Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group using image quality and motion artifact grading scale	This will be assessed by blinded attending radiologist/ resident radiologist. The above mentioned grading scale scores motion artifact and image quality on a 1 to 4 and 0 to 3 scales as follows: Image quality: 1 (excellent images, with very high confidence in diagnostic content), 2 (good images, with confidence in diagnostic content), 3 (fair images, with reservations about diagnostic content), 4 (poor nondiagnostic image), Motion artifact: 0 (no motion artifact); (minimal motion artifact not interfering with diagnostic content); (moderate motion artifact degrading diagnostic content); (severe motion artifact resulting in non diagnostic image)	1-2 weeks (average time to get MRI results)
Change in duration of MRI exam-Comparing time stamp (ending time of exam minus beginning time of exam) of MRI in CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group	Total length of time from beginning to end of MRI scan will be recorded and compared between groups, by subtracting the start time of the exam from the end time of the exam.	At the end of MRI exam, which typically ranges from 15-90 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Mark Liszewski, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Saleh RS, Patel S, Lee MH, Boechat MI, Ratib O, Saraiva CR, Finn JP. Contrast-enhanced MR angiography of the chest and abdomen with use of controlled apnea in children. Radiology. 2007 Jun;243(3):837-46. doi: 10.1148/radiol.2433060155.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019-10682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No