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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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
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
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.
- Conditions
- Pregnancy, Fear of Childbirth, Antenatal Education
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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
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.
- First posted18 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filiz Okumuş, Assoc. Prof. Dr., Study chair, Atlas University
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Midwife-Led Antenatal Perineal Massage Education on Pregnancy Empowerment, Self-Efficacy for Normal Birth, and Fear of Childbirth
- ClinicalTrials.gov ID
- NCT07593326
- Acronym / sponsor ID
- APM-EDU / APM-EDU-SILIFKE-2026-001
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Midwife-Led Antenatal Perineal Massage EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midwife-Led Antenatal Perineal Massage EducationThe 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. | Behavioural | APM Education Group |
Primary outcome
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.
2 secondary outcomes
Change in Self-Efficacy for Normal Birth
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyra Dilek Soydan, Master's degree student contact
Filiz Okumuş, Assoc. Prof. Dr. study chair
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyra Dilek Soydan, Master's degree student (+905533187543 ext. +90 212 761 87, soydansumeyradilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pregnancy Empowerment (time frame: Baseline and 4 weeks after completion of the education program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.