- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07802210
Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease
Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease: A Randomized Controlled Trial
Sickle-cell disease (SCD) is a genetic disorder that affects hemoglobin, the molecule in red blood cells responsible for carrying oxygen. The disease causes red blood cells to become rigid and sickle-shaped, leading to blockages in blood flow and subsequent pain and organ damage (World Health Organization (WHO),2025).
Patients with sickle cell disease suffer from various complications of the disease during their lifetime, including anemia, sickle cell crises, acute chest syndrome, stroke, renal failure, retinal detachment and priapism. However, unforeseen and chronic pain crisis are the most common symptoms reported by the patients which are considered as the most common causes of referral to the emergency department and hospital to receive medical care in sickle cell patients (Poku, Atkin,& Kirk,.2023).
Objective(s) of the study:
- To evaluate the effectiveness of Innovative Educational Methods on self-efficacy in children with sickle cell anemia.
- To evaluate the effectiveness of Innovative Educational Methods on self-care capacity in children with sickle cell anemia.
- To find out the relationship between the effectiveness of Innovative Educational Methods on self-efficacy, self-care capacity and demographic characteristics of children with sickle cell anemia.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: aula I Al Ali, Phd student
- Número de teléfono: 0096407733617988
- Correo electrónico: ula.ibrahim1204a@conursing.uobaghdad.edu.iq
Ubicaciones de estudio
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Irak
- Pediatric Hematology Center - Ibn Al-Baladi Maternity & Children Hospital and Hereditary Blood Diseases Center, Al-Karamah Teaching Hospital, Baghdad government.
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Contacto:
- MOHAMMED Alnedawi
- Número de teléfono: 07730994914
- Correo electrónico: hamadly994@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- children with sickle cell anemia and visited Ibn Al-Baladi ,Al-Karamah center for hereditary blood diseases
- age 12-18 years
- being able to read and write
- agrees and willing to participate in the study
Exclusion Criteria:
- children who have a history of mental illness
- children with advanced complications of SCD, such as multi-system organ damage
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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Experimental: video intervention arm
participation in this arm will watch video
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Participants in this group will watch an educational video lasting under 5 minutes.
The video covers key information about anemia, including its definition, pathophysiology, symptoms, underlying causes, potential complications, and preventive pain crisis in simple way by use AI programs to generation it ."
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Experimental: game intervention arm
participation in this arm will play educational game
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Participants in this group will play an educational game .
The game covers key information about anemia, including its definition, pathophysiology, symptoms, underlying causes, potential complications, and preventive pain crisis in simple way by use AI programs to generation it .
|
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Sin intervención: control arm
participation on this arm will not receive any video or game
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
self-care capacity level
Periodo de tiempo: pre and immediately post intervention and post 2 after 1 month
|
The Appraisal of Self-Care Agency Scale-Revised (ASA-R) According to Orem's self-care theory, Kearney and Fleischer originally developed this scale to assess the health-related self-care capacity level The scale consists of 15 items,
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pre and immediately post intervention and post 2 after 1 month
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self efficacy
Periodo de tiempo: pre and immediately post intervention and post 2 after 1 month
|
Sickle Cell Self-Efficacy Scale (SCSES): The Sickle Cell Self-Efficacy Scale, adapted from Edwards et al. (2001), was used to assess patients' abilities to manage their SCD and carry out daily activities effectively. |
pre and immediately post intervention and post 2 after 1 month
|
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UB.SCD.adolescent.pt
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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