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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07137741
Enrollment
52
Registered
2025-08-22
Start date
2023-07-01
Completion date
2024-08-30
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infants

Keywords

Family Integrated Care

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.

Interventions

BEHAVIORALFICare 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

Sponsors

Yongkang Maternal and Child Health Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
head circumference6 monthsTo 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.
body weight6 monthsTo 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.
body length6 monthsTo measure a preterm infant's length: extend body, align head/heel, use a length board, read to 0.1cm, repeat, record.
STAI scores6 monthsSTAI (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.
PSOC scores6 monthsPSOC (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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026