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Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women (APM-EDU)

2026년 5월 12일 업데이트: Atlas University

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

152

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Silifke
      • Mersin, Silifke, 터키 (Türkiye), 33960
        • Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic
        • 연락하다:
        • 수석 연구원:
          • Sümeyra Dilek Soydan, Master's degree

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Pregnancy Empowerment
기간: Baseline and 4 weeks after completion of the education program
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.
Baseline and 4 weeks after completion of the education program

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Self-Efficacy for Normal Birth
기간: Baseline and 4 weeks after completion of the education program
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.
Baseline and 4 weeks after completion of the education program
Change in Fear of Childbirth
기간: Baseline and 4 weeks after completion of the education program
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.
Baseline and 4 weeks after completion of the education program

기타 결과 측정

결과 측정
측정값 설명
기간
Immediate Change in Antenatal Perineal Massage Knowledge
기간: Baseline and immediately after completion of the education program
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.
Baseline and immediately after completion of the education program

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Filiz Okumuş, Assoc. Prof. Dr., Atlas University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 15일

기본 완료 (추정된)

2026년 11월 15일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 12일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • APM-EDU-SILIFKE-2026-001
  • E-22686390-050.99-96214 (기타 식별자: Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared because the study involves pregnant women and the informed consent documents do not include permission for sharing individual-level participant data with external researchers. Aggregate study results may be reported in scientific publications.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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