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CompletedNCT06958458Updated Sep 21, 2026

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

An interventional study of Mother Integrated Care in Mothers, Premature and Empowerment, sponsored by University of Yalova. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Mothers
  • Premature
  • Empowerment

Keywords

  • Empowerment
  • Neonatal
  • Premature
  • Mothers
  • Nursing
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 67 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Yalova is the lead sponsor of 61 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMother 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Within the first 72 hours of hospitalization, prior to discharge

  2. 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.

    Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge

  3. 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.

    Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge

  4. 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.

    Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge

  5. 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.

    Time frame: Within the first 72 hours of hospitalization, prior to discharge

07

Study locations

1 site
  • Yalova University
    Yalova, 77200, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06958458
Lead sponsor
University of Yalova
Responsible party
Emel AVÇİN (Assistant Professor, University of Yalova) — Principal investigator
First posted
May 6, 2025
Start date
Aug 30, 2025
Primary completion
Aug 30, 2026
Completion
Sep 1, 2026
Last update
Sep 21, 2026

Study contacts

EMEL AVÇİN, Doctor
principal investigator · Adiyaman University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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