Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women

NCT07593326 | Not Yet Recruiting

• 2 other identifiers: APM-EDU-SILIFKE-2026-001E-22686390-050.99-96214
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Fear of Childbirth; Antenatal Education

Keywords

Antenatal perineal massage; Midwife-led education; Primiparous pregnant women; Pregnancy empowerment; Self-efficacy for normal birth; Fear of childbirth; Vaginal birth; Pelvic health; Routine antenatal care

Outcome Measures

Primary Outcomes (1)

• Change in Pregnancy Empowerment

  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 Outcomes (2)

• Change in Self-Efficacy for Normal Birth

  Baseline and 4 weeks after completion of the education program

• Change in Fear of Childbirth

  Baseline and 4 weeks after completion of the education program

Other Outcomes (1)

• Immediate Change in Antenatal Perineal Massage Knowledge

  Baseline and immediately after completion of the education program

Study Arms (2)

Control Group

NO INTERVENTION

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.

APM Education Group

EXPERIMENTAL

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

Interventions

Midwife-Led Antenatal Perineal Massage Education BEHAVIORAL

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.

APM Education Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic

Mersin, Silifke, 33960, Turkey (Türkiye)

Location

Study Officials

• Filiz Okumuş, Assoc. Prof. Dr.

  Atlas University

  STUDY CHAIR

Central Study Contacts

Sümeyra Dilek Soydan, Master's degree student

CONTACT

+905533187543; soydansumeyradilek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied because the intervention is an educational intervention and participants and the intervention provider cannot be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to the control and intervention groups using a non-randomized, sequential allocation approach. To minimize contamination between groups and reduce the possibility that control participants may access the educational intervention, data will first be collected from the control group. After completion of control group data collection, the intervention group will receive midwife-led antenatal perineal massage education in addition to routine antenatal care.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)