NCT06958471

Brief Summary

This study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. Premature birth can be a stressful and anxiety-inducing experience for mothers, which may negatively impact their self-confidence and ability to establish an emotional bond with their baby. Structured and individualized developmental care education provided in the neonatal intensive care unit (NICU) enhances mothers' knowledge and promotes their active participation in the care process, thereby strengthening their maternal roles. Increased self-efficacy helps mothers to take a more active and conscious role in their infant's care, while stronger maternal attachment plays a critical role in the infant's emotional and neurodevelopmental health. Therefore, the integration and dissemination of such supportive educational interventions within the healthcare system are essential steps that can positively influence both maternal and infant health outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

April 18, 2025

Last Update Submit

February 13, 2026

Conditions

Keywords

PrematureIndividualized Developmental CareAttachmentSelf EfficacyMaternal

Outcome Measures

Primary Outcomes (2)

  • Self-Efficacy

    Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The General Self-Efficacy Scale consists of 17 items. The total score can range from 17 to 85; higher scores indicate a greater belief in self-efficacy.

    The first three days of hospitalization and one month after hospitalization

  • Maternal Attachment Levels

    Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104; higher scores indicate a stronger level of maternal attachment.

    The first three days of hospitalization and one month after hospitalization

Study Arms (2)

Individualized Developmental Care Education Group

EXPERIMENTAL

Before the mother is discharged from the hospital after delivery (within 24 hours for a vaginal birth and within 72 hours for a cesarean section), a brochure titled "Your Premature Baby" prepared by the researcher will be provided. The content of the "Infant Care and Nutrition" booklet to be given to mothers will include information on breastfeeding, infant care, home environment, screening tests, immunization, common problems, and other related topics. In the second and third weeks, individualized developmental care training tailored to the needs of the newborn will be provided. This training will cover topics such as environmental adjustments (light, noise, temperature), kangaroo care, infant massage, non-nutritive sucking, and parent-infant bonding. In the fourth week, the mothers' application of the training and their knowledge levels regarding premature infant care will be assessed.

Behavioral: Individualized Developmental Care Education Group

Control group

NO INTERVENTION

During the hospitalization of the premature infant, routine nursing education provided in the clinic will be delivered to the mother by the unit nurse. These routine trainings and information sessions include the following: A brief information session of approximately 5 minutes, usually given to all mothers within the first 24 hours after birth, covering topics such as breast milk expression, breastfeeding positions, and the benefits of breast milk. Mothers selected for kangaroo care are given information regarding hand hygiene and personal cleanliness. On weekdays, between 1:00 p.m. and 2:00 p.m., the neonatologist provides information to parents about the general condition of their baby in the NICU. To prevent ethical concerns arising from the implementation of the study in terms of the control group, after the posttest is completed, the researcher will provide the control group families with the information they need.

Interventions

An educational program will be implemented for the mothers in the intervention group throughout the hospitalization period of their premature infants, in line with the objectives of the study. P1:Pretests for the mothers will be completed within the first three days of the infant's admission to the neonatal intensive care unit (NICU). Mothers will be given a brochure titled "Your Premature Baby", prepared by the researcher, which includes information about the NICU and its staff, visiting hours/conditions, and breast milk expression times. P2:Education will be provided on the characteristics, feeding, and care of premature infants. P3:Mothers will receive training on environmental regulations (temperature, light, sound), kangaroo care,non-nutritive sucking, and parent-infant interaction. Each training session will be delivered each lasting no longer than 30-45 minutes. P4:A final training session will be provided on home care for the premature infant.

Individualized Developmental Care Education Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe sample consists of mothers whose premature babies are hospitalized in the NICU.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The mother must have a premature baby born between 22 and 32 weeks gestation, admitted to a level 3 NICU.
  • The baby's stay in the level 3 NICU must be at least one month.
  • The mother must not have any diagnosed psychiatric disorders.
  • The baby must not have severe congenital anomalies incompatible with life.
  • The mother must be literate and open to communication.
  • The mother must be willing and volunteer to participate in the research.

You may not qualify if:

  • The baby's stay in the NICU must be at least one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Avçin

Yalova, 77200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • EMEL AVÇİN, Doctor

    University of Yalova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled and Quasi-experimental research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 6, 2025

Study Start

April 7, 2025

Primary Completion

August 29, 2025

Study Completion

September 30, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations