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StressLEGO MRINCT04172909

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

A study testing LEGO Bricks MRI and Mock MRI tube in people with Stress and Anesthesia, run by Montefiore Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Anesthesia, Children, Only
What is being tested?
LEGO Bricks MRI and Mock MRI tube
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
24 Feb 2020to 1 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

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.

Read more

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)
Read the 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).

Being tested
LEGO Bricks MRI, Mock MRI tube
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEGO Bricks MRIOther

    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

  • Mock MRI tubeOther

    Mock MRI tube will be used by the child life specialist to prepare the child for MRI

Study groups in NCT04172909
Study groupRoleWhat they receive
Child life group with LEGO bricksExperimentalPatients in this group will be prepped by a Certified Child Life Specialist with the use of LEGO bricks model MR
Receives: Other: LEGO Bricks MRI
Control groupNo interventionAge 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.
Child life group with Mock MRI tubeExperimentalPatients in this group will be prepped by a Certified Child Life Specialist with the use of a Mock MRI tube
Receives: Other: Mock MRI tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 90 minutes (duration of MRI exam)

Secondary outcomes (3)

  1. 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).

    Measured: At time of enrollment (Baseline) and at the end of MRI exam, which typically ranges from 15-90 minutes

  2. 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)

    1. (minimal motion artifact not interfering with diagnostic content)
    2. (moderate motion artifact degrading diagnostic content)
    3. (severe motion artifact resulting in non diagnostic image)

    Measured: 1-2 weeks (average time to get MRI results)

  3. 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.

    Measured: At the end of MRI exam, which typically ranges from 15-90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start24 Feb 2020
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Feb 2022 (estimated)

Why it stopped: Expired IRB approval 12/12/2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172909
Sponsor's protocol ID
2019-10682
Other IDs
2019
Acronym
LEGO MRI
Status last verified
Feb 2022
First submitted
10 Nov 2019
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 17517937

Questions about this trial

What is this clinical trial studying?

A study testing LEGO Bricks MRI and Mock MRI tube in people with Stress and Anesthesia, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who need anesthesia - Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group (time frame: Up to 90 minutes (duration of MRI exam)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172909, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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