The Effect of Individualized Developmental Care Education

NCT ID: NCT06958471

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Self Efficacy Attachment Maternal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled and Quasi-experimental research
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Individualized Developmental Care Education Group

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.

Group Type EXPERIMENTAL

Individualized Developmental Care Education Group

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individualized Developmental Care Education Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* The baby's stay in the NICU must be at least one month.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Yalova

OTHER

Sponsor Role lead

Responsible Party

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Emel AVÇİN

Lecturer Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EMEL AVÇİN, Doctor

Role: PRINCIPAL_INVESTIGATOR

University of Yalova

Locations

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Emel Avçin

Yalova, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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EMEL AVÇİN, Doctor

Role: CONTACT

05534524243

ŞEYDA CAN, Ass Professor

Role: CONTACT

05366850312

Facility Contacts

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Yalova Provincial Health Directorate

Role: primary

0226 817 74 07

Other Identifiers

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Emel Avcin Indı. Deve. Care

Identifier Type: -

Identifier Source: org_study_id

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