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

NCT ID: NCT07137741

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

traditional model of hospital care

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

FICare nursing method guided by Swanson's caring theory

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongkang Maternal and Child Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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huijie zhu

chief nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yongkang maternal and Child Health Hospital

Guli, Zhejiang, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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YongkangMCHH

Identifier Type: -

Identifier Source: org_study_id

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