NCT07763041

Brief Summary

This randomized controlled trial aims to evaluate the effect of Meleis' Transitions Theory-based Quick Response (QR) code-supported infant care education on maternal self-confidence, maternal attachment, and infant health among primiparous mothers whose infants are hospitalized in the neonatal intensive care unit (NICU). Participants were randomly assigned to either an intervention group or a control group using block randomization. Mothers in the intervention group received face-to-face infant care education before discharge, a printed infant care guide containing QR codes linked to educational videos, and instructions on how to use a mobile application. Mothers in the control group received routine care and discharge education provided by the NICU. Maternal self-confidence, maternal attachment, and infant health outcomes were assessed before discharge and at one and three months after discharge. This study is expected to provide evidence regarding the effectiveness of QR code-supported infant care education in improving maternal adaptation and infant health outcomes following NICU discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

June 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 3, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

Maternal self-confidenceinfant care educationmaternal attachmentMeleis' Transition Theoryneonatal intensive care unit

Outcome Measures

Primary Outcomes (3)

  • Maternal Self-Confidence

    Maternal self-confidence was assessed using the Pharis Self-Confidence Scale. The scale consists of 13 items, with total scores ranging from 13 to 65. Higher scores indicate higher levels of maternal self-confidence.

    Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge

  • Maternal Attachment

    Maternal attachment was assessed using the Maternal Attachment Scale. The scale consists of 26 items, with total scores ranging from 26 to 104. Higher scores indicate higher levels of maternal attachment.

    Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge

  • Infant Health

    Infant health assessed using the Infant Health Assessment Form, including physical growth (weight, length, and head circumference), breastfeeding, urination and stool frequency, non-breastmilk feeding, common infant health problems (gas, fever, vomiting, oral thrush, diaper rash, nasal congestion), and hospital visits

    Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge

Study Arms (2)

QR Code-Supported Infant Care Education

EXPERIMENTAL

Mothers received face-to-face infant care education based on Meleis' Transitions Theory before discharge, together with a printed infant care guide containing QR codes linked to educational videos and instructions for using the mobile application developed for the study. Routine neonatal intensive care unit care was also provided.

Behavioral: QR Code-Supported Infant Care Education

Routine Care

NO INTERVENTION

Mothers received routine neonatal intensive care unit care, discharge education, and follow-up services without any additional structured infant care education.

Interventions

Face-to-face infant care education based on Meleis' Transitions Theory, supported by a printed infant care guide containing QR codes linked to educational videos and a mobile application developed for the study.

QR Code-Supported Infant Care Education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous mothers with a singleton birth,
  • Aged 18 years or older,
  • Able to read and communicate in Turkish,
  • Owning a smartphone with internet access and having sufficient digital literacy to use QR code applications,
  • No diagnosed psychiatric disorder,
  • Mothers whose infants had been hospitalized in the neonatal intensive care unit for at least one month,
  • Willing to participate and providing written informed consent,
  • Infants with a gestational age of ≥34 weeks,
  • Infants without life-threatening congenital, neurological, gastrointestinal, or genetic disorders requiring surgical intervention or expected to affect long-term prognosis.

You may not qualify if:

  • Mothers who did not continue in the post-discharge follow-up period,
  • Participants whose mother or infant died (exitus) during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Aslınur T GÜZELYAZICI

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 13, 2026

Study Start

June 2, 2025

Primary Completion

February 26, 2026

Study Completion

February 26, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations