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

6 de maio de 2026 atualizado 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).

Visão geral do estudo

Status

Concluído

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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 -

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de abril de 2025

Conclusão Primária (Real)

10 de janeiro de 2026

Conclusão do estudo (Real)

20 de janeiro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 696

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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