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PregnancyAPM-EDUNCT07593326

Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women

A study testing Midwife-Led Antenatal Perineal Massage Education in people with Pregnancy and Fear of Childbirth, run by Atlas University at 1 site in Turkey (Türkiye).

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Fear of Childbirth, Antenatal Education
What is being tested?
Midwife-Led Antenatal Perineal Massage Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2026to 31 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • Planning vaginal birth
  • Able to use a smartphone
  • Having internet access
  • Willing to participate in the study and providing informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sümeyra Dilek Soydan, Master's degree student contact

+905533187543 ext. +90 212 761 87

soydansumeyradilek@gmail.com

Turkey (Türkiye)1 site
  • Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic

    Mersin, Silifke, 33960

    Sümeyra Dilek Soydan, Master's degree, 05533187543 ext. +90 212 761 87, soydansumeyradilek@gmail.com

    Sümeyra Dilek Soydan, Master's degree

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Midwife-Led Antenatal Perineal Massage 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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Midwife-Led Antenatal Perineal Massage EducationBehavioural

    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.

Study groups in NCT07593326
Study groupRoleWhat they receive
Control GroupNo interventionParticipants 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 GroupExperimentalParticipants 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.
Receives: Behavioral: Midwife-Led Antenatal Perineal Massage Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 4 weeks after completion of the education program

Secondary outcomes (2)
  1. Change in Self-Efficacy for Normal Birth

    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.

    Measured: Baseline and 4 weeks after completion of the education program

  2. Change in Fear of Childbirth

    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.

    Measured: Baseline and 4 weeks after completion of the education program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start15 May 2026 (estimated)
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593326
Sponsor's protocol ID
APM-EDU-SILIFKE-2026-001
Other IDs
E-22686390-050.99-96214
Acronym
APM-EDU
Status last verified
May 2026
First submitted
12 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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