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Completed

NCT Number: NCT06958458

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

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 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.

Primary outcomes

  1. Parental Stress in the Neonatal Intensive Care Unit

    Time frame: First visit, before 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).

  2. Maternal Attachment

    Time frame: First visit, before discharge, 1 month after discharge, 3 months 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.

  3. The Mother's Perceived Parenting Self-Efficacy

    Time frame: First visit, before discharge, 1 month after discharge, 3 months after discharge

    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.

  4. Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants

    Time frame: First visit, before discharge, 1 month after discharge, 3 months after discharge

    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.

  5. Newborn Comfort Behavior

    Time frame: First visit, before discharge

    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.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
Sep 16, 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.

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