Visual Information Booklet and Anxiety in Preschool Children Undergoing Sedated MRI
The Effect of a Visual Information Booklet on Preprocedural Anxiety in Preschool Children Undergoing Magnetic Resonance Imaging Under Sedation: A Prospective Randomized Controlled Trial
This study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet called "MR Maceram" ("My MRI Adventure"). Families received the booklet at the anesthesia outpatient clinic before the scan day.
On the MRI day, children's anxiety was assessed in the waiting area and again in the preparation area before intravenous cannulation and sedative medication. Parents completed an anxiety questionnaire, and children's cooperation during intravenous cannulation was recorded. The main comparison was children's anxiety in the preparation area. The study was conducted at Kocaeli University Faculty of Medicine Hospital in Türkiye and is being registered after completion.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kocaeli
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İzmit, Kocaeli, Turquía (Türkiye), 41380
- Kocaeli University Faculty of Medicine Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children aged 3 to 6 years scheduled to undergo MRI under sedation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent.
Exclusion Criteria:
- Use of sedative or anxiolytic medication before the procedure.
- Emergency MRI.
- Acute pain, marked agitation, clinical instability, or communication or cooperation difficulties severe enough to prevent reliable assessment using the study scales.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Standard Verbal Information
Children and their families received routine verbal information about the MRI and sedation process at the anesthesia outpatient clinic. They did not receive the illustrated booklet. |
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Experimental: MR Maceram Booklet and Standard Verbal Information
Children and their families received routine verbal information plus the illustrated "MR Maceram" booklet at the anesthesia outpatient clinic before the MRI day. Families could review the booklet with their child before the scan. |
An age-appropriate illustrated booklet explaining hospital arrival, waiting, intravenous cannulation, sedation, the MRI scan, and recovery. It was given at the anesthesia outpatient clinic before the MRI day in addition to routine verbal information. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child Anxiety Before IV Cannulation (mYPAS-T2)
Periodo de tiempo: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Anxiety in the MRI Waiting Area (mYPAS-T1)
Periodo de tiempo: Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
|
Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
|
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Parental State Anxiety (STAI-S)
Periodo de tiempo: Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
|
Parental state anxiety was assessed using the State-Trait Anxiety Inventory, State subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
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Child Cooperation During IV Cannulation
Periodo de tiempo: Periprocedural (MRI day), during IV cannulation before sedative administration.
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Cooperation was assessed using a three-category observational scale: 0, good cooperation; 1, partial resistance; and 2, marked resistance. |
Periprocedural (MRI day), during IV cannulation before sedative administration.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Murat Tekin, MD, Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GOKAEK-2026/07/38
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared with other researchers. The informed consent specified that study data would be accessible only to the research team.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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