- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07593001
TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
THE EFFECT OF THE TRAINING GIVEN ON TIME MANAGEMENT DURING HAEMODIALYSIS ON ANXIETY AND FEAR IN CHILDREN
Aim: This study aims to determine the effect of time management training on anxiety and fear levels in children undergoing haemodialysis treatment. It is anticipated that the structured time management training provided to children will contribute to the treatment process.
Method: This study has a randomised controlled experimental design. The study was conducted at the Gaziantep University Sahinbey Research and Application Hospital Children's Nephrology Diseases Hemodialysis Unit between 1 November 2025 and 1 April 2026. The study sample consisted of children aged 9-12 undergoing hemodialysis treatment at this unit. The sample group was randomly divided into intervention and control groups. The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later. The control group received routine care. Data were collected using a questionnaire, the State-Trait Anxiety Inventory for Children, and the Medical Procedure Fear Scale.
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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-
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Gaziantep, Turquía (Türkiye), 27310
- Gaziantep University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 9-12,
- Children who can speak and understand Turkish,
- Children without communication problems,
- Children without learning disabilities,
- Children approved by their families,
- Children without physical disabilities.
Exclusion Criteria:
- Children who refuse to participate in the study,
- Children who do not speak Turkish,
- Children with communication problems,
- Children with learning disabilities,
- Children with intellectual disabilities.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Capacitación
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The intervention group received training after the pre-test, and the training's effectiveness was evaluated one week and one month later.
There is no actual intervention, just rutin care
|
|
Sin intervención: Control
Rutin care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the State Anxiety Inventory (Pre-training)
Periodo de tiempo: 2 months
|
After obtaining their consent during the first interview, the State Anxiety Inventory, was administered as pre-tests.
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2 months
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the Medical Procedure Fear Scale (Pre-training)
Periodo de tiempo: 2 mounts
|
After obtaining their consent during the first interview the Medical Procedure Fear Scale was administered as pre-tests.
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2 mounts
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the State Anxiety Inventory, (Post test)
Periodo de tiempo: 4 months
|
When evaluating the results of the first measurement one week after training (Final test 1)) State Anxiety Inventory was assessed.
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4 months
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the Medical Procedure Fear Scale (Post test)
Periodo de tiempo: 4 months
|
When evaluating the results of the first measurement one week after training (Final test 1)) the Medical Procedure Fear Scale was assessed.
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4 months
|
|
the State Anxiety Inventory (Post test)
Periodo de tiempo: 5 mounts
|
When evaluating the results of the second measurement one month after training (Final test 2)) the the State Anxiety Inventory was assessed.
|
5 mounts
|
|
the Medical Procedure Fear Scale (Post test)
Periodo de tiempo: 5 mounts
|
When evaluating the results of the second measurement one month after training (Final test 2)) the Medical Procedure Fear Scale was assessed.
|
5 mounts
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Raina M, Shah R, Hu J, Pember B, Cahill T, Bunchman T, Yap HK, McCulloch M. The global health burden of pediatric chronic kidney disease: An analysis of the Global Burden of Disease database from 1990 to 2021. PLoS One. 2025 May 27;20(5):e0323257. doi: 10.1371/journal.pone.0323257. eCollection 2025.
- Park, M. J. (2023). Anemia in children with chronic kidney disease: Current insights. Children's Kidney Journal, 7(3), 201-210.
- Panzarino V, Lesser J, Cassani FA. Pediatric Chronic Kidney Disease. Adv Pediatr. 2022 Aug;69(1):123-132. doi: 10.1016/j.yapd.2022.03.008.
- Hosseini T, Hooshmandja M, Noaparast M, Mojtahedzadeh R, Mohammadi A. Virtual reality exposure therapy to decrease anxiety before surgical invasive procedures in hemodialysis patients: an interventional study. BMC Nephrol. 2024 Jan 24;25(1):30. doi: 10.1186/s12882-024-03461-w.
- Francis, A., et al. (2024). Key pediatric considerations from the KDIGO 2024 CKD guidelines. JAMA Pediatrics, 178(5), 433-440.
- Cirillo L, De Chiara L, Innocenti S, Errichiello C, Romagnani P, Becherucci F. Chronic kidney disease in children: an update. Clin Kidney J. 2023 Apr 24;16(10):1600-1611. doi: 10.1093/ckj/sfad097. eCollection 2023 Oct.
- Akinkugbe, O., et al. (2024). Systematic review of CKD progression mechanisms in pediatric patients. Pediatric Nephrology, 39(4), 789-802.
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
- GaziantepU
- SBF.YLP.26.05 (Otro número de subvención/financiamiento: Gaziantep University Scientific Research Project)
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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