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Empowering First-Time Mothers (Empowering)

2026年11月1日 更新者:Hend Reda Elkest、Tanta University

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.

調査の概要

詳細な説明

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

研究の種類

介入

入学 (実際)

200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Tanta、エジプト
        • 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
    • Gharbia Governorate
      • Tanta、Gharbia Governorate、エジプト
        • Tanta University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Knowledge of primigravida women about breast feeding
時間枠:During the third trimester of pregnancy), immediately after delivery, and at 3 months postpartum.

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.

二次結果の測定

結果測定
メジャーの説明
時間枠
The Postpartum Bonding Questionnaire
時間枠:Immediately after delivery and at 3 months postpartum.

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.
Mother infant attachment scale
時間枠:immediately after delivery and at 3 months follow-up

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
Maternal Satisfaction of Telelactation
時間枠:at 3-month postpartum

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年1月1日

一次修了 (実際)

2025年1月1日

研究の完了 (実際)

2025年9月30日

試験登録日

最初に提出

2026年10月19日

QC基準を満たした最初の提出物

2026年10月23日

最初の投稿 (実際)

2026年10月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 762-1-2025

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

data is available with corresponding author

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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