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

Primary Purpose

Stress, Anesthesia, Children, Only

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LEGO Bricks MRI
Mock MRI tube
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Child life group with LEGO bricks

Control group

Child life group with Mock MRI tube

Arm Description

Patients in this group will be prepped by a Certified Child Life Specialist with the use of LEGO bricks model MR

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 this group will be prepped by a Certified Child Life Specialist with the use of a Mock MRI tube

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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)
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.

Full Information

First Posted
November 10, 2019
Last Updated
February 28, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04172909
Brief Title
LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.
Acronym
LEGO MRI
Official Title
LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Expired IRB approval 12/12/2020
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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: LEGO Bricks model MRI (A model of the MRI machine and adjacent control room made out of LEGO bricks) 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)
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anesthesia, Children, Only, Anxiety, MRI, Sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two experimental groups including the LEGO Bricks group, and the Mock MRI tube group, as well as a retrospective age matched control group.
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child life group with LEGO bricks
Arm Type
Experimental
Arm Description
Patients in this group will be prepped by a Certified Child Life Specialist with the use of LEGO bricks model MR
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Child life group with Mock MRI tube
Arm Type
Experimental
Arm Description
Patients in this group will be prepped by a Certified Child Life Specialist with the use of a Mock MRI tube
Intervention Type
Other
Intervention Name(s)
LEGO Bricks MRI
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Mock MRI tube
Intervention Description
Mock MRI tube will be used by the child life specialist to prepare the child for MRI
Primary Outcome Measure Information:
Title
Number of participants who need anesthesia - Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group
Description
Monitor whether or not the child needs anesthesia to successfully complete MRI exam
Time Frame
Up to 90 minutes (duration of MRI exam)
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
At time of enrollment (Baseline) and at the end of MRI exam, which typically ranges from 15-90 minutes
Title
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
Description
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)
Time Frame
1-2 weeks (average time to get MRI results)
Title
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
Description
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.
Time Frame
At the end of MRI exam, which typically ranges from 15-90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Liszewski, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17517937
Citation
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.
Results Reference
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LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.

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