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

6 mai 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 avril 2025

Achèvement primaire (Réel)

10 janvier 2026

Achèvement de l'étude (Réel)

20 janvier 2026

Dates d'inscription aux études

Première soumission

21 avril 2026

Première soumission répondant aux critères de contrôle qualité

6 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 696

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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