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

May 12, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Silifke
      • Mersin, Silifke, Turkey (Türkiye), 33960
        • Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic
        • Contact:
        • Principal Investigator:
          • Sümeyra Dilek Soydan, Master's degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Midwife-Led Antenatal Perineal Massage Education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pregnancy Empowerment
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy for Normal Birth
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Change in Antenatal Perineal Massage Knowledge
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Investigators

  • Study Chair: Filiz Okumuş, Assoc. Prof. Dr., Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on Midwife-Led Antenatal Perineal Massage Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe