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Empowering First-Time Mothers (Empowering)

2026년 11월 1일 업데이트: 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.

연구 개요

상세 설명

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

연구 유형

중재적

등록 (실제)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Tanta, 이집트
        • 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, 이집트
        • Tanta University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Knowledge of primigravida women about breast feeding
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
The Postpartum Bonding Questionnaire
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 1일

기본 완료 (실제)

2025년 1월 1일

연구 완료 (실제)

2025년 9월 30일

연구 등록 날짜

최초 제출

2026년 10월 19일

QC 기준을 충족하는 최초 제출

2026년 10월 23일

처음 게시됨 (실제)

2026년 10월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 1일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 762-1-2025

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

data is available with corresponding author

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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