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The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit

6 de mayo de 2026 actualizado por: Kübra Koç Sarıkaya, Zonguldak Bulent Ecevit University

The Effect of Family-Centered Care Practices In Pediatric Intensive Care Unit On Parental Satisfaction And Anxiety Levels

This study aims to evaluate the effects of family-centered care practices on parental satisfaction and anxiety levels in a pediatric intensive care unit (PICU).

Descripción general del estudio

Estado

Terminado

Descripción detallada

Admission of a child to the pediatric intensive care unit (PICU) is one of the most stressful experiences a family can face. Parents of critically ill children frequently experience high levels of anxiety, helplessness, and loss of parental role. Family-centered care (FCC) is a philosophy of care that recognizes the family as an essential component of the child's care team, emphasizing partnership, participation, and information sharing between healthcare providers and families.Although FCC has been increasingly advocated in pediatric critical care settings, its systematic implementation and measurable impact on parental outcomes remain insufficiently studied in the Turkish PICU context.This study will be conducted in the Pediatric Intensive Care Unit (PICU) of Kastamonu Training and Research Hospital, Kastamonu, Turkey. Kastamonu Training and Research Hospital is a tertiary-level public hospital serving the Kastamonu province and surrounding regions.his is a quasi-experimental study with an intervention group and a control group. A total of 80 parents will be enrolled: 40 in the intervention group and 40 in the control group. Participants will be recruited consecutively. Parents in the control group will receive standard care, while parents in the intervention group will receive a structured family-centered care protocol in addition to standard care.Parents assigned to the intervention group will participate in a structured FCC protocol delivered by trained PICU nurses, which includes:

Active parental participation in care: Parents will be encouraged and supported to participate in their child's daily care activities such as comfort care, positioning, and feeding where clinically appropriate.

Structured informational meetings: Parents will receive regular, planned verbal and written information from the nursing staff and medical team regarding their child's condition and care plan.

Family-centered care education booklet: Parents will be provided with an informational booklet developed specifically for the PICU environment at Kastamonu Training and Research Hospital, covering what to expect during the ICU stay, how to communicate with the care team, and how to actively participate in care.he control group will receive routine standard care as currently practiced in the unit, without the structured FCC protocol or the educational booklet.

Data Collection

Questionnaires will be administered at two time points:

T1 - Baseline: Within 24 hours of PICU admission T2 - Discharge: Within 24 hours before PICU discharge

Outcome Measures

The following validated instruments will be used:

State-Trait Anxiety Inventory (STAI): Measures parental anxiety at admission and discharge.

EMPATHIC-30 Scale: Measures parental satisfaction with PICU care at discharge. Family-Centered Care Scale: Measures the degree to which parents feel included, respected, and supported in the care process - at admission and discharge.

Expected Outcomes It is hypothesized that parents in the FCC intervention group (n=40) will demonstrate significantly lower anxiety scores and significantly higher satisfaction and family-centered care perception scores compared to the control group (n=40) at discharge.

Tipo de estudio

Intervencionista

Inscripción (Actual)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Kastamonu, Turquía (Türkiye), 37000
        • Kastamonu Training and Research Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Mother of a child admitted to the PICU of Kastamonu Training and Research Hospital
  2. Child aged 0-18 years
  3. PICU stay expected to be at least 48 hours
  4. Able to communicate verbally in Turkish
  5. Willing to provide written informed consent

Exclusion Criteria:

  1. Mother with a known diagnosed psychiatric disorder
  2. Child admitted for end-of-life or palliative care only
  3. Mother unable to be physically present in the hospital
  4. Father or non-maternal primary caregiver
  5. Participation in another clinical study simultaneously -

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention Group Control Group

Kol 1 - Intervention Group:

Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge.

Kol 2 - Control Group:

Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge.

A structured family-centered care (FCC) protocol was implemented by trained PICU nurses. The protocol consisted of three components: (1) active parental participation in daily care activities such as comfort care, positioning, and feeding where clinically appropriate; (2) structured informational meetings providing regular verbal and written information about the child's condition and care plan; and (3) provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. The intervention was applied throughout the PICU stay. Outcome measures were collected at admission (baseline) and within 24 hours before discharge.
Experimental: arm1 Intervention Group arm 2 Control Group

Kol 1 - Intervention Group:

Parents in this group received a structured family-centered care (FCC) protocol in addition to standard care. The protocol included active parental participation in daily care activities, structured informational meetings with the nursing and medical team, and provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. Questionnaires were administered at PICU admission and within 24 hours before discharge.

Kol 2 - Control Group:

Parents in this group received routine standard care as currently practiced in the PICU of Kastamonu Training and Research Hospital, without any structured family-centered care protocol or educational booklet. Questionnaires were administered at PICU admission and within 24 hours before discharge.

A structured family-centered care (FCC) protocol was implemented by trained PICU nurses. The protocol consisted of three components: (1) active parental participation in daily care activities such as comfort care, positioning, and feeding where clinically appropriate; (2) structured informational meetings providing regular verbal and written information about the child's condition and care plan; and (3) provision of a family-centered care education booklet developed specifically for the PICU of Kastamonu Training and Research Hospital. The intervention was applied throughout the PICU stay. Outcome measures were collected at admission (baseline) and within 24 hours before discharge.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception
Periodo de tiempo: At PICU admission (baseline) and within 24 hours before discharge Within 24 hours before PICU discharge At PICU admission (baseline) and within 24 hours before discharge

Parental Anxiety Level Parental anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale consists of two subscales: state anxiety (STAI-I) and trait anxiety (STAI-II), each containing 20 items scored between 20-80. Higher scores indicate higher anxiety levels.

Parental Satisfaction Parental satisfaction will be measured using the EMPATHIC-30 Scale, a validated instrument designed to measure parent satisfaction in pediatric intensive care units. The scale consists of 30 items rated on a 5-point Likert scale. Higher scores indicate higher satisfaction levels.

At PICU admission (baseline) and within 24 hours before discharge Within 24 hours before PICU discharge At PICU admission (baseline) and within 24 hours before discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: KÜBRA KOÇ SARIKAYA, MSN, kuubra.koc@hotmail.com

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de abril de 2025

Finalización primaria (Actual)

10 de enero de 2026

Finalización del estudio (Actual)

20 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 696

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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