- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07900932
Empowering First-Time Mothers (Empowering)
Empowering First-Time Mothers: The Effect of Digital Lactation Nursing Support on Breastfeeding Achievement and Maternal-Infant Outcomes
This randomized controlled trial aims to evaluate the effect of digital lactation nursing support on breastfeeding achievement and maternal-infant outcomes among first-time mothers.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study evaluates a digital lactation nursing support intervention delivered through online educational sessions and ongoing communication using digital platforms. The intervention is designed to provide breastfeeding education, address mothers' questions and concerns, and support breastfeeding initiation and continuation during the postpartum period.
Eligible first-time mothers are assigned to an intervention group receiving digital lactation nursing support in addition to standard care or a control group receiving standard care alone. The intervention includes four structured online educational sessions during the last month of pregnancy, followed by continued breastfeeding support through WhatsApp for three months after delivery.
Study outcomes include breastfeeding knowledge, early initiation of breastfeeding, exclusive breastfeeding, maternal-infant bonding and attachment, and maternal satisfaction with digital lactation support. Outcomes are assessed after delivery and at three months postpartum, according to the study protocol
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tanta, Egypte
- The study was carried out within the antenatal and postnatal outpatient units of three prominent hospitals in Tanta City, which together serve as central hubs for maternal and child health services. These included Tanta University Hospital, functioning u
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypte
- Tanta University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- First-time pregnant women (primigravida).
- Women in the third trimester of pregnancy.
- Women who are literate.
- Women who own a smartphone capable of installing and using the required digital applications.
- Women with a singleton, viable, term pregnancy without identified fetal congenital anomalies.
- Women without medical or psychological disorders that meet the study's exclusion criteria.
- Women willing to participate and provide written informed consent.
Exclusion Criteria:
- Multigravida women.
- Women who are illiterate.
- Women with multiple pregnancies.
- Women with identified fetal congenital anomalies.
- Women with medical or psychological disorders
- Women who do not have access to a compatible smartphone.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Digital Lactation Nursing Support group (intervention group)
Participants assigned to the digital lactation nursing support group received standard hospital care plus a structured digital lactation nursing support program. The program included four weekly, synchronous online educational sessions delivered via Zoom during the last month of pregnancy, with each session lasting approximately 30-45 minutes. WhatsApp was used to share educational materials, facilitate interactive discussions, answer breastfeeding-related questions, and provide individualized guidance. Individual breastfeeding support continued via WhatsApp for three months postpartum |
A structured digital lactation nursing support program based on self-efficacy principles. The intervention was delivered through four synchronous online educational sessions using Zoom, conducted once weekly over four consecutive weeks during the last month of pregnancy. Each session lasted approximately 30-45 minutes, and participants were organized into subgroups of approximately 10 women. The sessions covered: (1) the benefits of breastfeeding for mothers and infants and the importance of early initiation; (2) breast milk composition and breastfeeding techniques; (3) factors influencing breastfeeding success, anticipated challenges, and coping strategies; and (4) recognition and management of common breastfeeding problems. Educational materials included PowerPoint presentations, instructional videos, animations, scenario-based discussions, and an electronic handbook. WhatsApp was used for sharing materials, interactive discussions, clarification of information, and individualized |
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Aucune intervention: Standard Hospital Care Group (control goup)
Participants assigned to the control group received standard hospital care without the additional structured digital lactation nursing support program. Standard care was provided according to the routine hospital protocols at the participating hospitals. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Knowledge of primigravida women about breast feeding
Délai: During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.
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Total score on the breastfeeding knowledge section of the structured questionnaire, ranging from 0 to 38, with higher scores indicating greater breastfeeding knowledge. including its definition, benefits for both the infant and the mother, different types of breast milk, and the role and effectiveness of colostrum. It also addressed the recommended time for initiating breastfeeding, its optimal duration, and practical components such as proper techniques and breastfeeding positions. Furthermore, the tool examined knowledge regarding the indicators of adequate, insufficient, and excessive breastfeeding. In addition, it explored awareness of common breastfeeding related problems as breast engorgement, cracked nipples, and inverted nipples highlighting for each (their definition, risk factors, signs and symptoms, possible complications, effects on the infant, and appropriate maternal self-care practices for relief.). |
During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Postpartum Bonding Questionnaire
Délai: Immediately after delivery and at 3 months postpartum.
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This tool consisted of 25 items designed to evaluate maternal attitudes toward their newborns. Each item offers six response options, ranging from "always" to "never." For positively worded statements, responses are scored from 0 (always) to 5 (never), whereas negatively worded statements are scored in reverse order, from 5 (always) to 0 (never). The total score ranges from 0 to 125, with higher scores indicating poorer bonding. |
Immediately after delivery and at 3 months postpartum.
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Mother infant attachment scale
Délai: immediately after delivery and at 3 months follow-up
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It comprises 15 statements that reflect different maternal attitudes and perceptions toward the child, Responses are rated on a five- point Likert scale ranging from strongly agree to strongly disagree. Each item is scored from 1 to 5, with 5 representing the most favorable response and 1 representing the least favorable response. The total score ranges from 15 to 75. Higher total scores indicate poorer mother-infant attachment, whereas lower scores reflect stronger attachment. |
immediately after delivery and at 3 months follow-up
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Maternal Satisfaction of Telelactation
Délai: at 3-month postpartum
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The tool comprised 11 items that explored multiple dimensions of telelactation. Responses were rated on a three-point Likert scale: 3 = satisfied, 2 = partially satisfied, and 1 = not satisfied. Total scores ranged from 11 to 33 and were categorized as not satisfied (<18), partially satisfied (18 to <25), and satisfied (≥25). |
at 3-month postpartum
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 762-1-2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
data is available with corresponding author
Informations sur les médicaments et les dispositifs, documents d'étude
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