- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
84
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Ankara, Tyrkia (Türkiye)
- Lokman Hekim University Ankara Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: Routine Care
Mothers received routine neonatal intensive care unit care, discharge education, and follow-up services without any additional structured infant care education.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal Self-Confidence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Aslınur T GÜZELYAZICI, Ankara Medipol University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. juni 2025
Primær fullføring (Faktiske)
26. februar 2026
Studiet fullført (Faktiske)
26. februar 2026
Datoer for studieregistrering
Først innsendt
3. august 2026
Først innsendt som oppfylte QC-kriteriene
9. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- AYBU-PhD-QRNICU-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .