Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women (APM-EDU)
The Effect of Midwife-Led Antenatal Perineal Massage Education on Pregnancy Empowerment, Self-Efficacy for Normal Birth, and Fear of Childbirth
This study aims to evaluate the effect of midwife-led antenatal perineal massage education on pregnancy empowerment, self-efficacy for normal birth, and fear of childbirth among primiparous pregnant women. The study is designed as a controlled quasi-experimental study and will be conducted at the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital in Mersin, Turkey.
Eligible participants will be primiparous pregnant women aged 18-35 years, between 28 and 34 weeks of gestation, with a singleton pregnancy and a plan for vaginal birth. Participants in the intervention group will receive structured antenatal perineal massage education led by a midwife, in addition to routine antenatal care. Participants in the control group will receive routine antenatal care.
The primary outcome will be pregnancy empowerment. Secondary outcomes will include self-efficacy for normal birth, fear of childbirth, knowledge and preferences regarding antenatal perineal massage, and adherence to antenatal perineal massage practice.
調査の概要
詳細な説明
This controlled quasi-experimental study will evaluate the effect of a structured midwife-led antenatal perineal massage education program on pregnancy empowerment, self-efficacy for normal birth, and fear of childbirth among primiparous pregnant women. The study will be conducted at the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital in Mersin, Turkey, after ethics committee approval.
The study population will consist of pregnant women attending the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital. Eligible participants will be women aged 18-35 years who are at least primary school graduates, able to communicate in Turkish, between 28 and 34 weeks of gestation, primiparous, carrying a singleton pregnancy, planning a vaginal birth, able to use a smartphone, and have internet access. Women with an indication for planned cesarean section, a history of perineal surgery, an active genital infection or lesion, or cognitive, communication-related, or psychiatric conditions that prevent completion of study forms will be excluded.
The planned sample size is 152 pregnant women, with 76 participants in the intervention group and 76 participants in the control group. The sample size was calculated using G*Power version 3.1.9.7 based on a two-tailed test, a significance level of 0.05, statistical power of 80%, and an assumed medium effect size of Cohen's d = 0.50. The minimum required sample size was calculated as 64 participants per group, and the target sample size was increased to 76 participants per group to account for potential attrition or missing data.
Participants in the intervention group will receive structured midwife-led antenatal perineal massage education in addition to routine antenatal care. The educational content will include the importance of pelvic health, preparation for antenatal perineal massage, antenatal perineal massage technique, and maintenance of pelvic health. The intervention is intended to improve women's knowledge and practice of antenatal perineal massage and to support empowerment, confidence regarding normal birth, and reduction of fear related to childbirth. Participants in the control group will receive routine antenatal care provided at the study hospital.
Data will be collected using a Participant Information Form, the Antenatal Perineal Massage Knowledge and Preference Form, the Pregnancy Empowerment Scale, the Self-Efficacy Scale for Normal Birth, the Childbirth Attitudes Scale, and the Antenatal Perineal Massage Follow-up Form. The primary outcome will be change in pregnancy empowerment. Secondary outcomes will include change in self-efficacy for normal birth, change in fear of childbirth, antenatal perineal massage knowledge and preferences, and adherence to antenatal perineal massage practice.
Baseline data will be collected before the intervention. Post-intervention data will be collected after completion of the antenatal perineal massage education and follow-up period, according to the study protocol. The study is planned to be conducted between May 15, 2026 and December 31, 2026.
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:Sümeyra Dilek Soydan, Master's degree student
- 電話番号:+90 212 761 87 +905533187543
- メール:soydansumeyradilek@gmail.com
研究場所
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Silifke
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Mersin、Silifke、トルコ(Türkiye)、33960
- Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic
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コンタクト:
- Sümeyra Dilek Soydan, Master's degree
- 電話番号:+90 212 761 87 05533187543
- メール:soydansumeyradilek@gmail.com
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主任研究者:
- Sümeyra Dilek Soydan, Master's degree
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Women aged 18 to 35 years
- At least primary school graduates
- Able to communicate in Turkish
- Between 28 and 34 weeks of gestation
- Primiparous pregnant women
- Singleton pregnancy
- Planning vaginal birth
- Able to use a smartphone
- Having internet access
- Willing to participate in the study and providing informed consent
Exclusion Criteria:
- Having an indication for planned cesarean section
- History of perineal surgery
- Presence of active genital infection or genital lesion
- Cognitive, communication-related, or psychiatric condition that may prevent completion of the study forms
- Refusal to participate in the study
- Withdrawal from the study during the study process
- Failure to complete the educational intervention
- Missing pre-test or post-test data
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:非ランダム化
- 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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介入なし:Control Group
Participants in the control group will receive routine antenatal care provided at the study hospital.
Data from the control group will be collected before the intervention group to minimize contamination and reduce the possibility of access to the educational intervention.
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実験的:APM Education Group
Participants in the intervention group will receive structured midwife-led antenatal perineal massage education in addition to routine antenatal care.
The intervention will be implemented after completion of control group data collection to minimize contamination between groups.
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The intervention is a structured midwife-led antenatal perineal massage education program delivered to primiparous pregnant women in the third trimester.
The educational content includes the importance of pelvic health, preparation for antenatal perineal massage, antenatal perineal massage technique, and maintenance of pelvic health.
The program is designed to improve knowledge and practice regarding antenatal perineal massage and to support pregnancy empowerment, self-efficacy for normal birth, and reduction of fear of childbirth.
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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 Pregnancy Empowerment
時間枠:Baseline and 4 weeks after completion of the education program
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Pregnancy empowerment will be assessed using the Pregnancy Empowerment Scale.
The outcome will be evaluated by comparing scores between baseline and post-intervention assessment.
Higher scores indicate higher pregnancy empowerment.
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Baseline and 4 weeks after completion of the education program
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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 Self-Efficacy for Normal Birth
時間枠:Baseline and 4 weeks after completion of the education program
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Self-efficacy for normal birth will be assessed using the Self-Efficacy Scale for Normal Birth.
The scale will be administered at baseline and 4 weeks after completion of the education program.
Change in self-efficacy for normal birth will be evaluated by comparing baseline and post-test scores.
Higher scores indicate higher perceived self-efficacy for normal birth.
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Baseline and 4 weeks after completion of the education program
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Change in Fear of Childbirth
時間枠:Baseline and 4 weeks after completion of the education program
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Fear of childbirth will be assessed using the Childbirth Attitudes Scale.
The scale will be administered at baseline and 4 weeks after completion of the education program.
Change in fear of childbirth will be evaluated by comparing baseline and post-test scores.
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Baseline and 4 weeks after completion of the education program
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Immediate Change in Antenatal Perineal Massage Knowledge
時間枠:Baseline and immediately after completion of the education program
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Antenatal perineal massage knowledge will be assessed using the Antenatal Perineal Massage Knowledge and Preference Form developed for this study.
The form will be administered at baseline and immediately after completion of the education program.
Immediate change in knowledge will be evaluated by comparing baseline and immediate post-intervention scores.
Higher scores indicate higher knowledge regarding antenatal perineal massage.
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Baseline and immediately after completion of the education program
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Filiz Okumuş, Assoc. Prof. Dr.、Atlas University
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
- APM-EDU-SILIFKE-2026-001
- E-22686390-050.99-96214 (その他の識別子:Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee)
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
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