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Trials / Withdrawn

WithdrawnNCT04172909

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Montefiore Medical Center · Academic / Other
Sex
All
Age
4 Years – 10 Years
Healthy volunteers
Accepted

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: 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)

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).

Conditions

Interventions

TypeNameDescription
OTHERLEGO Bricks MRILEGO 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
OTHERMock MRI tubeMock MRI tube will be used by the child life specialist to prepare the child for MRI

Timeline

Start date
2020-02-24
Primary completion
2022-02-01
Completion
2022-02-01
First posted
2019-11-21
Last updated
2022-03-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04172909. Inclusion in this directory is not an endorsement.