Empowering Mothers in the NICU

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.

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Key information

Conditions

Mothers Behavior Empowerment Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Social Behavior Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yalova University

Yalova, 77200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mother Integrated Care

Behavioral

In order to empower mothers whose premature infants have been hospitalized in the neonatal intensive care unit (NICU) for at least three days, a four-step neonatal care training program will be provided. Through the empowerment of the mother, the empowerment of the family will also be supported. The family will no longer be considered as visitors but will be involved in the infant's care in the NICU as parents. Data collection forms will be completed before the training begins, one day prior to discharge, and one week after discharge.

Primary outcomes

Parental Stress in the Neonatal Intensive Care Unit

Time frame: 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.

The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to assess the level of parental perception of stressors arising from the physical and psychosocial environment of the intensive care unit. The scale consists of 34 items across three dimensions: Sights and Sounds, Infant Appearance and Behavior, and Parental Role Alteration. Higher scores on the scale indicate higher levels of parental stress (minimum: 0, maximum: 170).
Maternal Attachment

Time frame: 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.

The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104. A higher score indicates a higher level of maternal attachment.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

Empowering Mothers With Hospitalized Infants in the Neonatal Intensive Care Unit Through Integrated Care: A Randomized Controlled Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: May 6, 2025
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed