The Effect of Family-Integrated Care Based on Swanson's Theory of Caring on Premature Infants

August 22, 2025 updated by: huijie zhu, Yongkang Maternal and Child Health Hospital
Previous studies have demonstrated that the implementation of FICare in single-family neonatal units is associated with a reduced risk of late-onset sepsis among preterm infants, a shorter hospital length of stay, a lower risk of rehospitalization, and improved breastfeeding rates.However, the impact of FICare, guided by Swanson's caring theory, on the growth and development of newborns, as well as on parental anxiety and their sense of parenting competence, remains unclear. To address this gap, the investigators conducted a cohort study to investigate these outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Guli, Zhejiang, China, 321300
        • Yongkang maternal and Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • gestational age ranging from 28 to 36 weeks
  • stable vital signs for at least 24 hours
  • parental accompaniment of preterm infants during hospitalization

Exclusion Criteria:

  • preterm infants with severe congenital or genetic disorders
  • preterm infants with dysfunction of vital organs
  • preterm infants requiring mechanical life support
  • preterm infants requiring surgical intervention
  • preterm infants with a birth weight below 500 grams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
traditional model of hospital care
Experimental: FICare nursing method guided by Swanson's caring theory

encompasses the following five dimensions: Understanding: A neonatologist provided a comprehensive explanation regarding the developmental progress of premature infants, potential complications, and essential aspects of nursing care to ensure the family gained a thorough understanding of the care requirements for premature infants.

Accompaniment: Two nursing guides provided essential support to parents of newborns in the NICU, helping to alleviate the anxiety and sense of helplessness among family members and fostering a relationship of trust between the medical staff and the families.

Help: A neonatal nurse played a guiding role in facilitating parental involvement in the daily care of premature infants, which encompassed feeding guidance, introduction of complementary foods, skin care, and related aspects.

Empowerment: A psychological counselor was assigned to provide psychological counseling and guidance to new parents, offering appropriate emotional support and assisting them in a
Behavioral: FICare nursing method guided by Swanson's caring theory

encompasses the following five dimensions: Understanding: A neonatologist provided a comprehensive explanation regarding the developmental progress of premature infants, potential complications, and essential aspects of nursing care to ensure the family gained a thorough understanding of the care requirements for premature infants.

Accompaniment: Two nursing guides provided essential support to parents of newborns in the NICU, helping to alleviate the anxiety and sense of helplessness among family members and fostering a relationship of trust between the medical staff and the families.

Help: A neonatal nurse played a guiding role in facilitating parental involvement in the daily care of premature infants, which encompassed feeding guidance, introduction of complementary foods, skin care, and related aspects.

Empowerment: A psychological counselor was assigned to provide psychological counseling and guidance to new parents, offering appropriate emotional support and assisting them in ac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
head circumference
Time Frame: 6 months
To measure a preterm infant's head circumference: use a soft tape, wrap snugly over supraorbital ridges and occipital protuberance, read to 0.1cm, repeat twice, record.
6 months
body weight
Time Frame: 6 months
To measure a preterm infant's weight: place on a calibrated, zeroed electronic scale (nappy only), ensure stillness, read to 0.1g, repeat twice, record with date/time.
6 months
body length
Time Frame: 6 months
To measure a preterm infant's length: extend body, align head/heel, use a length board, read to 0.1cm, repeat, record.
6 months
STAI scores
Time Frame: 6 months

STAI (State-Trait Anxiety Inventory) scores assess anxiety levels via two scales: State Anxiety (S-AI) measures temporary anxiety, Trait Anxiety (T-AI) assesses general anxiety proneness.

Each has 20 items, rated 1-4. Scores range 20-80; higher scores indicate greater anxiety. S-AI ≥40 suggests significant state anxiety; T-AI ≥40 may indicate trait anxiety.
6 months
PSOC scores
Time Frame: 6 months
PSOC (Parenting Sense of Competence Scale) scores assess parental self-efficacy and satisfaction. It has 17 items, rated 1-6, covering efficacy (confidence) and satisfaction (emotional engagement). Scores range 17-102; higher scores mean stronger. parenting competence.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongkang Maternal and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

August 7, 2025

First Submitted That Met QC Criteria

August 15, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YongkangMCHH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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