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

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).

Study Overview

• Status: Completed
• Conditions: Pediatric Intensive Care
• Intervention / Treatment: Behavioral: Family-Centered Care Protocol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Family-Centered Care Protocol; 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.	Behavioral: Family-Centered Care Protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Anxiety Level Parental Satisfaction Family-Centered Care Perception	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

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University
• Investigators: Principal Investigator: KÜBRA KOÇ SARIKAYA, MSN, kuubra.koc@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2025
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Family-Centered Care, Parental satisfaction
• Other Study ID Numbers: 696

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No