- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07845123
The Effect of a Mandala Coloring-Based Nursing Intervention on Perceived Nursing Image and Anxiety in Children Hospitalized in a Pediatric Clinic: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will be conducted as a randomized controlled trial at the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital. A total of 64 children meeting the inclusion criteria will be randomly assigned to the intervention (n=32) and control (n=32) groups. Children in the intervention group will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days, while the control group will receive routine clinical care. Data will be collected using a Descriptive Information Form, the Children's Perceived Nursing Image Scale, and the State Anxiety Inventory for Children. State anxiety will be evaluated at baseline, on the third day, and before discharge, while perceived nursing image will be evaluated at baseline and before discharge.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gamze AKAY, 1
- Número de teléfono: 05314536661
- Correo electrónico: gamzeakay_25@artvin.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Elif Simay KOÇ, 2
- Número de teléfono: +90 507 149 97 46
- Correo electrónico: elifsimay.koc@kilis.edu.tr
Ubicaciones de estudio
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Central
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Kilis, Central, Turquía (Türkiye)
- Reclutamiento
- Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central
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Contacto:
- Elif Simay KOÇ, 2
- Número de teléfono: +90 507 149 97 46
- Correo electrónico: elifsimay.koc@kilis.edu.tr
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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:
- Aged between 8 and 11 years
- Hospitalized in the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital
- Expected hospitalization for at least three more days based on clinical evaluation and having no clinical impediment to completing the 3-day intervention protocol
- Able to read and write in Turkish with adequate cognitive ability to understand questions
- Willingness of both child and parent to participate, with written informed consent provided by the parent
- Being able to communicate at an adequate level
Exclusion Criteria:
- Inability to complete the 3-day intervention protocol due to early discharge or other reasons
- Deterioration of the child's clinical condition preventing continuation of the application
- Inability to complete data collection or outcome measurement procedures
- Request by the child or parent to withdraw from the study at any stage
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 |
|---|---|
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Sin intervención: Control Group
Routine clinical care will be applied to the control group. No action will be taken. |
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Experimental: Experimental Group
Children will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days during hospitalization, and their anxiety and perceived nursing image will be evaluated. |
Children in the intervention group will receive a mandala coloring-based nursing intervention conducted by the researcher for 20 minutes once daily over three consecutive days. The session will take place in the patient's room or a quiet area within the pediatric clinic at a time that does not interfere with routine care. Each child will be provided with an individual mandala coloring book and a set of 12 colored pencils. Prior to the session, brief communication will be established to explain the activity, allowing the child full autonomy over color selection and coloring style without interference. Communication from the researcher will remain neutral, standardized, and age-appropriate. Children in the control group will receive routine clinical care only, with no mandala coloring or other distraction interventions applied. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Introductory Information Form
Periodo de tiempo: Baseline
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The Introductory Information Form was prepared by the researchers based on the relevant literature. The form consists of a total of 10 questions designed to assess the sociodemographic characteristics of the children and their parents, as well as information regarding hospitalization. It includes questions concerning variables such as the child's age, gender, grade level, previous hospitalization experience, duration of stay, and reason for admission, as well as the parent's age, education level, employment status, and family type. |
Baseline
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State Anxiety Level
Periodo de tiempo: Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the State Anxiety Inventory for Children (SAIC / STAIC). The scale consists of 20 items scored between 20 and 60, where higher scores indicate higher levels of state anxiety. |
Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Perceived Nursing Image
Periodo de tiempo: Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the Children's Perceived Nursing Image Scale. The scale consists of 35 items scored between 35 and 175, where higher scores indicate a more positive perception of the nursing image. |
Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gamze AKAY, 1, Artvin Coruh University
Publicaciones y enlaces útiles
Enlaces Útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Mandala Coloring in Children
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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