- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07763041
Effect of QR Code-Supported Infant Care Education on Maternal Self-Confidence, Maternal Attachment, and Infant Health in the NICU (NICU-QR)
9 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
84
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ankara, Turquia (Türkiye)
- Lokman Hekim University Ankara Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Maternal Self-Confidence
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Aslınur T GÜZELYAZICI, Ankara Medipol University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de junho de 2025
Conclusão Primária (Real)
26 de fevereiro de 2026
Conclusão do estudo (Real)
26 de fevereiro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
3 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- AYBU-PhD-QRNICU-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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