Midwife-Led Home-Based Postpartum Follow-up Program
Effectiveness of a Midwife-Led Home-Based Postpartum Follow-up Program on Breastfeeding Self-Efficacy, Sleep Quality, and Maternal Attachment: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
This study was designed as a parallel-group randomized controlled trial conducted among postpartum women at Elazig Fethi Sekin City Hospital in Türkiye. Participants were enrolled during the first 48 hours after birth and randomly allocated in a 1:1 ratio to an intervention group or a control group. Randomization was stratified according to mode of birth, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes.
Women assigned to the intervention group received a structured, midwife-led postpartum follow-up program in addition to routine care. The program included an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. The pre-discharge session addressed breastfeeding techniques, positioning and attachment, management of common breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and available sources of support. During the home visit, breastfeeding practices and postpartum needs were assessed, individualized counselling was provided, and identified problems were addressed. Telephone follow-up was used to reinforce previous education, assess ongoing concerns, and provide additional counselling when needed.
Women assigned to the control group received the routine postpartum care and discharge education provided by the hospital. They did not receive the structured home visit or telephone follow-up program during the study period.
The principal outcome was breastfeeding self-efficacy. Secondary outcomes included postpartum sleep quality and maternal attachment. Outcomes were assessed at baseline during the first 48 hours postpartum and again at six weeks postpartum using validated self-report instruments.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Elâzığ
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Elazig, Turkey、Elâzığ、トルコ（Türkiye）、23280
- Elazig Fethi Sekin City Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Aged 18 years or older Delivered a singleton live-born infant at term (37 weeks of gestation or later) Intended to breastfeed Able to communicate in Turkish Provided written informed consent Both the mother and infant were medically stable and eligible for discharge following routine postpartum care
Exclusion Criteria:
- A maternal or infant medical condition contraindicating breastfeeding A severe maternal or infant complication requiring prolonged hospitalization or intensive care A diagnosed maternal psychiatric disorder that could interfere with participation Inability to participate in the scheduled follow-up procedures
研究計画
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 |
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実験的：Structured Midwife-Led Postpartum Follow-up Program
Participants received routine postpartum care plus a structured, midwife-led follow-up program consisting of an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week.
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The program included a 15-minute individual education session before hospital discharge, a home visit of approximately 30 minutes during the second postpartum week, and telephone follow-up during the fourth postpartum week.
The program addressed breastfeeding technique, positioning and attachment, management of breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and individualized problem-solving.
Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.
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アクティブコンパレータ：Routine Postpartum Care
Participants received the routine postpartum care and discharge education provided by the hospital.
They did not receive the structured home visit or telephone follow-up program during the study period.
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Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.
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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 |
|---|---|---|
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Change in Breastfeeding Self-Efficacy Scale Score
時間枠：Baseline (within 48 hours postpartum) and six weeks postpartum
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Breastfeeding self-efficacy was assessed using the 33-item Breastfeeding Self-Efficacy Scale.
Each item is scored from 1 to 5, producing a total score ranging from 33 to 165.
Higher scores indicate greater breastfeeding self-efficacy.
Change from baseline to six weeks postpartum was evaluated.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Postpartum Sleep Quality Scale Score
時間枠：Baseline (within 48 hours postpartum) and six weeks postpartum
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Postpartum sleep quality was assessed using the 14-item Postpartum Sleep Quality Scale.
The total score ranges from 0 to 56, with higher scores indicating poorer postpartum sleep quality.
Change from baseline to six weeks postpartum was evaluated.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Change in Maternal Attachment Inventory Score
時間枠：Baseline (within 48 hours postpartum) and six weeks postpartum
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Maternal attachment was assessed using the 26-item Maternal Attachment Inventory.
Each item is scored from 1 to 4, producing a total score ranging from 26 to 104.
Higher scores indicate stronger maternal attachment.
Change from baseline to six weeks postpartum was evaluated.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Exclusive Breastfeeding Status
時間枠：Six weeks postpartum
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Exclusive breastfeeding status was assessed based on infant feeding during the preceding 24 hours.
Infants receiving only breast milk, with no other food or liquid except medicines, vitamins, or minerals, were classified as exclusively breastfed.
The outcome was recorded as yes or no.
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Six weeks postpartum
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SYO.26.04 (その他の助成金/資金番号：Fırat University Scientific Research Projects Coordination Unit)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
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
米国FDA規制機器製品の研究
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