- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07590791
Shared Reading for Pediatric Ophthalmic Education
Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hsin-Ming Liu
- Número de teléfono: +886-965873185
- Correo electrónico: angela89154@gmail.com
Ubicaciones de estudio
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Taiwan
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Taipei, Taiwan, Taiwán, 10449
- Mackay Memorial Hospital
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Contacto:
- Department of Ophthalmology
- Número de teléfono: 886-2-2543-3535
- Correo electrónico: mmhopheye@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 3 to 5 years.
- Parents or legal guardians capable of participating in parent-child shared reading (proficient in Traditional Chinese).
- Agreement to the administration of cycloplegic agents.
Exclusion Criteria:
- Parents or legal guardians who are not proficient in Traditional Chinese or are unwilling to participate in parent-child shared reading.
- Children aged under 3 years or 6 years and older.
- Refusal of cycloplegic agent administration.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Leaflet
Standard printed educational leaflet
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Standard printed educational leaflet for cycloplegic refraction exam.
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Comparador activo: Book
Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading
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Maisy Goes to the Eye Doctor
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Experimental: Customized book
Customized educational book on cycloplegic drops and refraction procedures, designed via generative AI, also for parent-child shared reading
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Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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visual analogue scale of anxiety
Periodo de tiempo: 1. Baseline, pre-intervention 2. 30 minutes after the intervention
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Pediatric anxiety levels will be quantified using a 0-10 scale supplemented by facial icons.
Participants will be shown the scale and asked to select the face or number that best matches how they feel at that moment.
The scale is anchored by "No anxiety" (0, happy face) and "Extreme anxiety" (10, distressed face).
Research assistants will provide a standardized prompt: "Point to the face that shows how you feel right now."
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1. Baseline, pre-intervention 2. 30 minutes after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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children's emotional manifestation scale (CEMS)
Periodo de tiempo: 30 minutes after the intervention
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This observational instrument consists of five behavioral categories: facial expression, vocalization, activity, interaction, and cooperation.
Each category is scored on a 5-point Likert scale (1 to 5), with a total score ranging from 5 to 25.
Higher scores represent higher levels of emotional distress and negative behaviors.
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30 minutes after the intervention
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Parent Satisfaction Scale
Periodo de tiempo: 30 minutes after the intervention
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The Parent Satisfaction Scale is a 10-item self-report questionnaire designed to evaluate the caregiver's perception of the quality of pediatric ophthalmic care. The scale assesses several key domains of the clinical encounter, including patient-centered communication, emotional support, clinician-parent partnership, and overall service quality. Scoring and Administration: Each item is scored using a 5-point Likert scale, with response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). A total satisfaction score is calculated by summing the responses, with higher scores (ranging from 10 to 50) indicating higher levels of parental satisfaction with the healthcare delivery and the educational intervention provided. |
30 minutes after the intervention
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Staff Satisfaction Scale
Periodo de tiempo: 30 minutes after the intervention
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The Staff Satisfaction Scale is a 7-item clinician-reported instrument designed to evaluate the clinical feasibility and perceived quality of a pediatric eye examination. The scale measures the nurse's observation of patient cooperation, parental engagement, and the effectiveness of the clinical workflow. Scoring and Administration: Following the patient's encounter, the attending ophthalmic nurse rates each statement using a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher aggregate scores indicate a more efficient clinical process and a higher level of professional satisfaction with the care delivery. |
30 minutes after the intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- 26MMHIS067e
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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