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

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

Patrocinadores

Patrocinador principal: Montefiore Medical Center

Fuente Montefiore Medical Center
Resumen breve

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)

Descripción detallada

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).

Estado general Recruiting
Fecha de inicio February 24, 2020
Fecha de Terminación July 1, 2021
Fecha de finalización primaria June 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of participants who need anesthesia - Comparing CL groups ((1) LEGO Bricks model MRI and (2) mock MRI tube groups) and Control group Up to 90 minutes (duration of MRI exam)
Resultado secundario
Medida Periodo de tiempo
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. 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 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 At the end of MRI exam, which typically ranges from 15-90 minutes
Inscripción 200
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: LEGO Bricks MRI

Descripción: 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

Etiqueta de grupo de brazo: Child life group with LEGO bricks

Tipo de intervención: Other

Nombre de intervención: Mock MRI tube

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

Etiqueta de grupo de brazo: Child life group with Mock MRI tube

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 4 Years

Edad máxima: 10 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Mark Liszewski, MD Principal Investigator Montefiore Medical Center
Contacto general

Apellido: Mark Liszewski, MD

Teléfono: 718-920-7748

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Montefiore Medical Center Faraz Ahmed 516-507-7344 [email protected]
Ubicacion Paises

United States

Fecha de verificación

June 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Montefiore Medical Center

Nombre completo del investigador: Mark Liszewski

Título del investigador: Principal investigator

Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Child life group with LEGO bricks

Tipo: Experimental

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

Etiqueta: Control group

Tipo: No Intervention

Descripción: 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.

Etiqueta: Child life group with Mock MRI tube

Tipo: Experimental

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

Acrónimo LEGO MRI
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Prevention

Enmascaramiento: Single (Investigator)

Fuente: ClinicalTrials.gov