- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07763041
Effect of QR Code-Supported Infant Care Education on Maternal Self-Confidence, Maternal Attachment, and Infant Health in the NICU (NICU-QR)
9. august 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Ankara, Tyrkiet (Türkiye)
- Lokman Hekim University Ankara Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
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Ingen indgriben: Routine Care
Mothers received routine neonatal intensive care unit care, discharge education, and follow-up services without any additional structured infant care education.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maternal Self-Confidence
Tidsramme: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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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.
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Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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Maternal Attachment
Tidsramme: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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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.
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Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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Infant Health
Tidsramme: Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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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
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Baseline (approximately 1 week before discharge and prior to the intervention), 1 month after discharge, and 3 months after discharge
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Aslınur T GÜZELYAZICI, Ankara Medipol University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juni 2025
Primær færdiggørelse (Faktiske)
26. februar 2026
Studieafslutning (Faktiske)
26. februar 2026
Datoer for studieregistrering
Først indsendt
3. august 2026
Først indsendt, der opfyldte QC-kriterier
9. august 2026
Først opslået (Faktiske)
13. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- AYBU-PhD-QRNICU-2026
Plan for individuelle deltagerdata (IPD)
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