- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07763041
Effect of QR Code-Supported Infant Care Education on Maternal Self-Confidence, Maternal Attachment, and Infant Health in the NICU (NICU-QR)
August 9, 2026 updated by: Aslınur TAŞKIN GÜZELYAZICI, Ankara Medipol University
The Effect of Meleis' Transition Theory-Based QR Code-Supported Infant Care Training on Maternal Self-Confidence, Maternal Attachment, and Infant Health Among Mothers of Infants Hospitalized in the Neonatal Intensive Care Unit
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial was conducted to evaluate the effects of a Quick Response (QR) code-supported infant care education program based on Meleis' Transitions Theory on maternal self-confidence, maternal attachment, and infant health among primiparous mothers of infants hospitalized in a neonatal intensive care unit (NICU).
Data were collected using the Descriptive Information Form, the Pharis Self-Confidence Scale, the Maternal Attachment Scale, and the Infant Health Assessment Form.
Participants were randomly assigned to the intervention (n=42) and control (n=42) groups using block randomization.
Mothers in the intervention group received face-to-face infant care education based on Meleis' Transitions Theory before discharge, a printed infant care guide containing QR codes linked to educational videos, and instructions on how to use the mobile application developed for the study.
Mothers in the control group received routine care and follow-up services provided by the neonatal intensive care unit.
Maternal self-confidence, maternal attachment, and infant health outcomes were assessed before discharge and at one and three months after discharge.
The intervention group demonstrated higher maternal self-confidence and maternal attachment scores throughout the follow-up period compared with the control group.
Infants in the intervention group also showed more favorable health outcomes, including improved growth indicators, higher breastfeeding frequency, and lower rates of common health problems and hospital visits.
The findings suggest that Meleis' Transitions Theory-based QR code-supported infant care education is an effective strategy for improving maternal self-confidence, maternal attachment, and infant health outcomes following NICU discharge.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Lokman Hekim University Ankara Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Mothers who did not continue in the post-discharge follow-up period,
- Participants whose mother or infant died (exitus) during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: QR Code-Supported Infant Care Education
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.
|
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.
|
|
No Intervention: Routine Care
Mothers received routine neonatal intensive care unit care, discharge education, and follow-up services without any additional structured infant care education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Self-Confidence
Time Frame: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
|
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
Time Frame: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
|
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
Time Frame: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aslınur T GÜZELYAZICI, Ankara Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2025
Primary Completion (Actual)
February 26, 2026
Study Completion (Actual)
February 26, 2026
Study Registration Dates
First Submitted
August 3, 2026
First Submitted That Met QC Criteria
August 9, 2026
First Posted (Actual)
August 13, 2026
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 9, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AYBU-PhD-QRNICU-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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