- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07647211
MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM (MIND-BF)
EFFECT OF MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM ON BREASTFEEDING OUTCOMES IN MOTHERS NOT EXCLUSIVELY BREASTFEEDING: A RANDOMIZED CONTROLLED TRIAL
연구 개요
상세 설명
Breastfeeding is one of the most important practices for improving maternal and infant health. However, many mothers experience difficulties maintaining exclusive breastfeeding during the postpartum period. Psychological stress, anxiety, low breastfeeding confidence, and difficulties adapting to motherhood may negatively affect breastfeeding behaviors and contribute to early supplementation with formula or other foods.
Mindfulness-based approaches have been increasingly used to support maternal psychological well-being and health-related behaviors. These approaches aim to increase awareness of present-moment experiences in a non-judgmental manner and may help mothers engage more consciously in the breastfeeding process. Previous studies suggest that mindfulness-based interventions may improve maternal coping, emotional regulation, and breastfeeding experiences. However, evidence regarding their effectiveness among mothers who are not exclusively breastfeeding remains limited.
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding awareness, breastfeeding self-efficacy, and exclusive breastfeeding rates among postpartum mothers who are not exclusively breastfeeding. Participants are randomly assigned to either a mindfulness-based breastfeeding education group or a control group receiving routine postpartum care. The intervention includes structured breastfeeding education combined with mindfulness-based practices conducted over four weeks. Outcomes are assessed at baseline, immediately after the intervention, and during follow-up assessments postpartum.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Elâzığ, 터키 (Türkiye), 23100
- Family Health Centres (FHCs) in the provincial centre of Elazığ, Türkiye
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Being 18 years of age or older, being in the first month postpartum, having a full-term, singleton, and healthy infant, and not exclusively breastfeeding the infant (i.e., using formula or other foods in addition to breast milk)
Exclusion Criteria:
- Having previously received mindfulness or similar training, having a diagnosed psychiatric disorder, and having any condition that impairs communication.
공부 계획
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 |
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실험적: Mindfulness-Based Breastfeeding Education Group
Participants received a 4-week mindfulness-based breastfeeding education program consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife.
The program combined breastfeeding education with mindfulness-based stress reduction techniques (breathing meditation, body scan, sitting meditation, mountain meditation, and loving-kindness meditation).
Practical breastfeeding training was supported using a doll and breast model.
Participants also received audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice, in addition to routine postpartum care.
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A 4-week mindfulness-based breastfeeding education program was implemented, consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife.
The intervention combined breastfeeding education with mindfulness-based stress reduction techniques, including breathing meditation, body scan meditation, sitting meditation, mountain meditation, and loving-kindness (Metta) meditation.
Practical breastfeeding training was provided using a doll and breast model to support skill acquisition.
Participants were also given audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice in addition to routine postpartum care.
다른 이름들:
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간섭 없음: Control Group
Participants received routine postpartum follow-up and standard breastfeeding counseling provided at Family Health Centres.
No additional mindfulness-based intervention was administered.
Counseling included brief education and support related to breastfeeding as part of standard care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mindful Breastfeeding Scale
기간: Baseline, 4th week postpartum, 4th month postpartum
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This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period.
The scale is unidimensional and was developed using a 5-point Likert scale.
Responses to the scale items range from "always" to "never."
The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.
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Baseline, 4th week postpartum, 4th month postpartum
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Kurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- 2023/5132
- 966799 (기타 식별자: fırat üniversitesi)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Mindfulness-Based Breastfeeding Education Group에 대한 임상 시험
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Qazvin University Of Medical Sciences완전한
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Qazvin University Of Medical Sciences알려지지 않은
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Oregon Health and Science UniversityMedical Research Foundation, Oregon완전한
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Eric Loucks알려지지 않은신체 활동 | 스트레스, 심리적 | 잠 | 우울 증상 | 다이어트 | 좌식 행동 | 외로움 | 감정 조절 | 마음챙김 | 음주, 청소년미국