Anxiety in Children and Families During MRI Under Anesthesia
The Relationship Between Anxiety Levels of Families and Children Undergoing Magnetic Resonance Imaging Under Anesthesia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure. The intervention consists of two main components:
Age-Appropriate Therapeutic Play: Children aged 2-7 (Pre-operational stage) receive symbolic medical play using toy kits and masks. Children aged 7-11 (Concrete operational stage) engage in interactive discussions and role-playing for 5-8 minutes.
Structured Parental Briefing: Parents receive a standardized oral briefing covering the MRI working principles, duration of the scan, the role of the anesthesia team, and the recovery process. This is followed by a Q&A session to address specific concerns.
The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center. This standard care includes a pre-anesthetic clinical assessment by the anesthesiology team, verification of fasting status (nil per os), and standard institutional monitoring procedures. Unlike the intervention group, participants in the control group do not receive age-appropriate therapeutic play or a structured, standardized parental briefing session prior to sedation. Interaction with medical staff remains limited to routine clinical and administrative procedures.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Afyonkarahisar, Turquía (Türkiye), 03030
- Afyonkarahisar Health Sciences University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age Range
- Procedure Type
- Consent
- Caregiver Presence
- Physical Status
Exclusion Criteria:
- Cognitive dysfunction
- Emergency status
- Psychiatric disorders
- Medical contraindications
- Communication barriers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: The intervention group
The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure.
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The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure. The intervention consists of two main components: Age-Appropriate Therapeutic Play: Children aged 2-7 (Pre-operational stage) receive symbolic medical play using toy kits and masks. Children aged 7-11 (Concrete operational stage) engage in interactive discussions and role-playing for 5-8 minutes. Structured Parental Briefing: Parents receive a standardized oral briefing covering the MRI working principles, duration of the scan, the role of the anesthesia team, and the recovery process. This is followed by a Q&A session to address specific concerns. |
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Sin intervención: The control group
The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Children's Preoperative Anxiety Levels
Periodo de tiempo: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
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Assessed using the Modified Yale Preoperative Anxiety Scale.
The total score ranges from a minimum value of 23.33 to a maximum value of 100.
Higher scores indicate a worse outcome (greater severity of preoperative anxiety in the child).
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Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parental Preoperative Anxiety and Information Requirement
Periodo de tiempo: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
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Assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
The APAIS is a 6-item instrument consisting of two distinct subscales: a 4-item anxiety subscale and a 2-item information requirement subscale.
Each item is rated on a 5-point Likert scale (1 to 5).
For the anxiety subscale, the scores range from a minimum value of 4 to a maximum value of 20.
For the information requirement subscale, the scores range from a minimum value of 2 to a maximum value of 10.
Higher scores on both subscales indicate a worse outcome (higher levels of parental anxiety and a greater need for information, respectively).
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Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
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Parental Preoperative and Postoperative Anxiety Levels
Periodo de tiempo: Measured at two distinct time points: preoperatively in the waiting room (post-intervention but before the induction of sedation) and postoperatively in the recovery room.
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Assessed using the Visual Analogue Scale (VAS) for anxiety.
The scale consists of a horizontal line where parents self-report their current anxiety intensity.
The scores range from a minimum value of 0 (representing 'no anxiety') to a maximum value of 10 (representing 'the worst possible anxiety').
Higher scores indicate a worse outcome (greater severity of parental anxiety).
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Measured at two distinct time points: preoperatively in the waiting room (post-intervention but before the induction of sedation) and postoperatively in the recovery room.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- AFSU-2026-MRI SEDATION
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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