Empowering Mothers in the NICU

February 13, 2026 updated by: Emel AVÇİN, University of Yalova

Empowering Mothers With Hospitalized Infants in the Neonatal Intensive Care Unit Through Integrated Care: 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 of admission to the unit, and pre-test data will be collected. One day before discharge and one week after discharge, questionnaire forms will be administered via WhatsApp.
Experimental: Mother Integrated Care Group

Mothers whose infants are admitted to the NICU will be contacted within the first 72 hours. Pre-test data (Information Form, Maternal Attachment Scale, and Parental Stressor Scale: Neonatal Intensive Care Unit) will be collected, and education will be planned through a face-to-face interview.

After meeting with the mother and administering the pre-test, the training date will be scheduled together with the researchers.

The training, which consists of four steps, is planned to be conducted with a two-day interval between each session.

The practices will be demonstrated on mannequins and supported by a PowerPoint presentation and visual materials. A booklet prepared specifically for the mothers will also be distributed.

After the training steps are completed, mothers will be encouraged to participate in their infant's care in cooperation with the NICU team.

One day before discharge and one week after discharge, questionnaire forms will be administered 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yalova

Investigators

  • Principal Investigator: EMEL AVÇİN, Doctor, Adiyaman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

February 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)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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