Clinical trial NCT06958458: The Role of Family Integrated Care in Maternal Empowerment
Official title: Empowerment of Mothers With Infants in the Neonatal Intensive Care Unit: Family Integrated Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Family
Premature
Empowerment
Keywords: Empowerment
Neonatal
Premature
Family
Nursing
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial (RCT) designed to evaluate the effectiveness of an intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. Through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. They are also educated on general hygiene and care tasks such as diaper changing and body cleaning. This model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. During this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. Family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. This model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.


Eligibility criteria: Inclusion Criteria:

* The newborn must be premature (gestational age \>28 and \<34 weeks),
* The infant must be admitted to the NICU and hospitalized for at least 3 days,
* The mother must be open to communication and cooperation,
* The mother must voluntarily agree to participate in the study,
* The mother must be literate,
* The mother must be able to speak and understand Turkish,
* The mother must be primiparous and experiencing motherhood for the first time,
* The mother must be over 18 years of age,
* Mothers in the intervention group must be present in the hospital for an average of 6-8 hours per day.

Exclusion Criteria:

* The newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis),
* The newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, Down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases),
* The newborn has a congenital heart defect requiring surgical intervention,
* The mother has a diagnosed psychiatric illness,
* The mother and/or father do not wish to participate in the study.

Withdrawal Criteria:

* The mother does not attend the training sessions during the study period,
* The mother fails to maintain cooperation throughout the study,
* The newborn is transferred to another healthcare center for any reason,
* The mother wishes to withdraw from the study,
* The newborn is diagnosed with a chronic illness during the study process.

Primary outcomes:
measure: Parental Stress in the Neonatal Intensive Care Unit
timeFrame: The mother will be asked to complete the scale form within the first 72 hours of admission to the unit, one day before discharge, and one week after discharge.
measure: Maternal Attachment
timeFrame: The mother will be asked to complete the scale form within the first 72 hours of admission to the unit, one day before discharge, and one week after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova University
Study officials:
affiliation: Yalova Unıversıty
name: EMEL AVÇİN, Doctor
role: PRINCIPAL_INVESTIGATOR
References: