Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit

Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit and the Impact of Their Integration Into Their Babies' Care Process on Maternal and Infant Outcomes: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Premature; Mothers; Empowerment
• Intervention / Treatment: Behavioral: Mother Integrated Care

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yalova, Turkey (Türkiye), 77200
    • Yalova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mother Integrated Care Group; Mothers whose babies are admitted to YYÜ will be contacted within the first 72 hours. Pre-test data (Information Form, Maternal Self-Efficacy, Attachment, Breastfeeding Self-Efficacy, Parental Stress, and Newborn Comfort Scales) will be collected, and the training schedule will be determined through face-to-face interviews. After the interview with the mother and the pre-test are completed, the training date will be determined in consultation with the researchers. The training, consisting of four stages, is planned to be conducted at a rate of one session per day. Procedures will be demonstrated using mannequins and supported by a PowerPoint presentation and visual materials. A prepared booklet will also be distributed to the mothers. After the training phases are completed, mothers will be encouraged to participate in care as part of a team effort. One day before discharge and one and three months after discharge, survey forms will be completed via WhatsApp.	Behavioral: Mother Integrated Care; 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 motherwill 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.
No Intervention: Control group; Mothers in this group will receive standard unit care and education. Data collection procedures will be the same as those used in the intervention group. The mother will be contacted within the first 72 hours after admission to the unit, and baseline data will be collected. One day before discharge, and one and three months after discharge, questionnaire forms will be completed via WhatsApp.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Stress in the Neonatal Intensive Care Unit	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).	First visit, before discharge
Maternal Attachment	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.	First visit, before discharge, 1 month after discharge, 3 months after discharge
The Mother's Perceived Parenting Self-Efficacy	The scale was developed to assess the perceived self-efficacy of mothers of premature infants in caring for their babies and understanding their needs. The scale consists of a total of 20 items, and scores range from 20 to 80. A higher score indicates an increase in the mother's perceived parenting self-efficacy.	First visit, before discharge, 1 month after discharge, 3 months after discharge
Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants	The scale consists of 18 positive items that assess mothers of preterm infants' perceptions of self-efficacy regarding breastfeeding and milk expression. The total score ranges from 18 to 90, with a high score indicating high breastfeeding self-efficacy.	First visit, before discharge, 1 month after discharge, 3 months after discharge
Newborn Comfort Behavior	The scale consists of six behavioral parameters that assess alertness, calmness/agitation, respiratory response or crying, body movements, facial tension, and muscle tone. Each parameter is scored on a scale of 1 to 5, and the total score ranges from 6 to 30. A high score indicates a decreased level of comfort in the newborn.	First visit, before discharge

Collaborators and Investigators

• Sponsor: University of Yalova
• Investigators: Principal Investigator: EMEL AVÇİN, Doctor, Adiyaman University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2025
• Primary Completion (Actual): August 30, 2026
• Study Completion (Actual): September 1, 2026

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Nursing; Empowerment; Premature; Neonatal; Mothers
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Behavior; Social Behavior; Premature Birth; Empowerment
• Other Study ID Numbers: Emel A. Family Integrated Care

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No