Mindfulness-Based Intervention in Primiparous Pregnant Women (MBCP)
Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
調査の概要
詳細な説明
Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.
Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ebru Solmaz, PhD
- 電話番号：+905377737260
- メール：esolmaz@agri.edu.tr
研究場所
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Ağrı、トルコ（Türkiye）
- Healthy Life Center Pregnancy School
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コンタクト：
- Ebru Solmaz, PhD
- 電話番号：+905377737260
- メール：esolmaz@agri.edu.tr
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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:
- Pregnant women aged 18 years and older
- Primiparous women
- Singleton pregnancy
- Gestational age between 28 and 32 weeks
- No known obstetric complications
- Ability to read and understand Turkish
- Attendance at the Pregnancy School of the Healthy Life Center
- Willingness to participate and provide written informed consent
- Willingness to participate in the mindfulness-based intervention program
Exclusion Criteria:
- Multiple pregnancy
- High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
- Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Substance or alcohol dependence
- Previous participation in a structured mindfulness, meditation, or similar awareness-based program
- Inability to attend intervention sessions regularly
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：Mindfulness-Based Intervention Group
Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation.
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A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly.
The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation.
Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.
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介入なし：Routine Antenatal Care Group
Participants will receive routine antenatal education and standard prenatal care.
No mindfulness-based intervention will be administered.
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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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Childbirth Self-Efficacy
時間枠：Baseline and 4 weeks after intervention
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Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
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Baseline and 4 weeks after intervention
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Fear of Childbirth
時間枠：Baseline and 4 weeks after intervention
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Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
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Baseline and 4 weeks after intervention
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Self-Compassion
時間枠：Baseline and 4 weeks after intervention
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Assessment of self-compassion using the Self-Compassion Scale.
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Baseline and 4 weeks after intervention
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- PMI-2026-01
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
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。