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

NCT07137741 | Completed

• 1 other identifier: YongkangMCHH
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Infants

Keywords

Family Integrated Care

Outcome Measures

Primary Outcomes (5)

• head circumference

  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

  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

  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

  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

  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

Study Arms (2)

control

NO INTERVENTION

traditional model of hospital care

FICare nursing method guided by Swanson's caring theory

EXPERIMENTAL

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

Interventions

FICare nursing method guided by Swanson's caring theory BEHAVIORAL

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

FICare nursing method guided by Swanson's caring theory

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yongkang Maternal and Child Health Hospital: lead

Study Sites (1)

Yongkang maternal and Child Health Hospital

Guli, Zhejiang, 321300, China

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: July 1, 2023
• Primary Completion: November 25, 2023
• Study Completion: August 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)