- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07705932
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers: A Randomized Controlled Trial
연구 개요
상세 설명
Breastfeeding is recognized as the optimal method of infant feeding and provides substantial health benefits for both infants and mothers. The World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first six months, and continued breastfeeding with appropriate complementary feeding up to two years of age or beyond. Despite these recommendations, exclusive breastfeeding rates remain below desired levels worldwide.
Successful breastfeeding is influenced by multiple psychological, educational, and sociocultural factors. Primiparous mothers frequently experience uncertainty, anxiety, inadequate confidence, and misconceptions regarding breastfeeding. Breastfeeding myths, such as concerns about insufficient milk supply or beliefs that certain maternal characteristics determine breastfeeding success, may negatively affect breastfeeding practices and continuation. Maternal anxiety has also been associated with reduced breastfeeding confidence and motivation.
Advances in information and communication technologies have created new opportunities for delivering breastfeeding education. Video-assisted educational interventions provide standardized, visually supported, and repeatedly accessible learning materials that may improve knowledge acquisition, reinforce practical skills, and increase maternal confidence. However, evidence regarding the effectiveness of structured video-assisted breastfeeding education on breastfeeding motivation, breastfeeding myths, and maternal state anxiety among primiparous women remains limited.
This study is designed as a parallel-group randomized controlled trial conducted in Family Health Centers in Iğdır Province, Türkiye. Eligible primiparous pregnant women will be randomly allocated to either a video-assisted breastfeeding education group or a routine care group. The educational intervention consists of three expert-developed video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths. Videos will be delivered weekly via WhatsApp during late pregnancy. Participants may view the videos as often as desired, and researchers will obtain feedback after each module through telephone or WhatsApp communication.
Women allocated to the control group will receive routine breastfeeding education provided within standard antenatal and postnatal healthcare services. Outcome assessments will be conducted before the intervention during pregnancy and again at eight weeks postpartum. The study aims to determine whether video-assisted breastfeeding education can improve breastfeeding-related psychological and behavioral outcomes compared with routine care alone.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women aged 18 years or older.
- Primiparous pregnant women.
- Gestational age between 32 and 36 weeks.
- Planning to breastfeed after delivery.
- Singleton pregnancy.
- Able to read and write in Turkish.
- Using WhatsApp.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- High-risk pregnancy or serious obstetric complications.
- Newborns with serious congenital anomalies or medical conditions requiring treatment and separation from the mother (e.g., dysphagia).
- Mothers with severe nipple abnormalities that may prevent breastfeeding.
- Withdrawal of informed consent at any stage of the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Video-Assisted Breastfeeding Education
Participants assigned to the intervention group will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants may watch the videos as often as needed and will receive follow-up through telephone or WhatsApp after each module to address questions and obtain feedback.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
|
Participants will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules developed based on current evidence and expert opinion.
The modules cover breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants will be able to watch the videos repeatedly at their convenience.
After each module, researchers will contact participants via telephone or WhatsApp to obtain feedback and answer questions.
|
|
간섭 없음: Routine Care
Participants assigned to the control group will receive routine antenatal and postnatal care, including standard breastfeeding education provided by healthcare professionals.
No additional video-assisted educational intervention will be provided.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Breastfeeding Motivation
기간: Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
|
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale to evaluate the effect of the video-assisted breastfeeding education program among primiparous women.
The Breastfeeding Motivation Scale consists of 23 items and five subscales.
Each item is rated on a 4-point Likert scale (1-4).
The scale does not provide a total score; each subscale is evaluated separately.
Higher subscale scores indicate higher breastfeeding motivation in the corresponding dimension.
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Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .