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

NCT07585903 | Completed DMC

• 1 other identifier: 696
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pediatric Intensive Care

Keywords

Family-Centered Care, Parental satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group Control Group

EXPERIMENTAL

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

arm1 Intervention Group arm 2 Control Group

EXPERIMENTAL

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

Interventions

Family-Centered Care Protocol BEHAVIORAL

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.

Intervention Group Control Group; arm1 Intervention Group arm 2 Control Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Kastamonu Training and Research Hospital

Kastamonu, 37000, Turkey (Türkiye)

Location

Study Officials

• KÜBRA KOÇ SARIKAYA, MSN

  kuubra.koc@hotmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EBE

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 14, 2026
• Study Start: April 19, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 20, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

TU (1)