Clinical trial NCT04172909: LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.
Official title: LEGO MRI: Decreasing the Need for Sedation, and Improving Patient Anxiety.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress
Anesthesia
Children, Only
Anxiety
MRI
Sedation
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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:

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).

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

Primary outcomes:
measure: Number of participants who need anesthesia - Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group
timeFrame: Up to 90 minutes (duration of MRI exam)
Secondary outcomes:
measure: 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.
timeFrame: At time of enrollment (Baseline) and at the end of MRI exam, which typically ranges from 15-90 minutes
measure: 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
timeFrame: 1-2 weeks (average time to get MRI results)
measure: 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
timeFrame: At the end of MRI exam, which typically ranges from 15-90 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Mark Liszewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.