Breastfeeding Education Through Clinical Demonstration for Primiparous Women to Prevent Sore Nipples and Engorgement

December 14, 2025 updated by: Eka Nurhayati, Gadjah Mada University

The Effect of Prenatal Breastfeeding Education Through Clinical Demonstrations for Primiparous Women to Prevent Sore Nipples and Engorgement

Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples.

Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.

This research uses quasi-experiments. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups. breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group. The outcome of this research is position, attachment, effective sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Several studies show that breastfeeding problems in the first days of birth pose a significant obstacle to successful breastfeeding. Among the most common breast problems experienced by mothers are breast abscesses, mastitis, nipple pain and sore nipples, engorgement, and flat or inverted nipples. Treatment for sore nipples and breast engorgement is mostly focused on medication. There is very little research that focuses on the impact of interventions regarding breastfeeding techniques carried out during the antenatal period to prevent sore nipples. Knowing the effect of breastfeeding position and attachment education through clinical demonstration in third-trimester primigravida pregnant women to prevent sore nipples and engorgement.

This research is an experimental study with a quasi-experimental design, the equivalent-time samples design. The population in this research is a third-trimester pregnant woman in the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis Community Health Centers. The sampling method in this research used simple random sampling. The number of samples in this study was 100 divided into 2, namely 50 intervention groups and 50 control groups.

breastfeeding education will be provided to pregnant women at 34-35 weeks of gestation, as led by a lactation counselor. The first session will take place at a puskesmas (public health center), where mothers will receive an e-booklet, followed by 40 minutes of hands-on clinical skills training for those in the intervention group. A second session will take place two weeks after the first session in the form of a home visit only for those in the intervention group.

The selection of respondents was determined based on predetermined inclusion criteria. Next, respondents will be confirmed via WhatsApp so that the enumerator can meet with the respondent to provide an explanation regarding the progress of the research and ask for their willingness to participate in the research by signing an informed consent.

Respondents in the control group did not receive any special intervention. Furthermore, respondents were asked to confirm whether they had given birth in both the intervention group and the control group. A home visit will be carried out by a lactation counselor and enumerator one week postpartum. The first visit to the mother to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples, and swollen breasts. The second home visit was carried out at 14 days postpartum to assess breastfeeding positioning and latching practices, assess the baby's sucking, and evaluate nipple pain, sore nipples and swollen breasts.

The outcome of this research is knowledge of breastfeeding techniques, position practice, and latching, evaluating the baby's sucking, nipple pain, sore nipples, and engorgement. T-test and chi-square will be used to test differences and similarities between study groups. Multiple logistic regression was used to analyze the impact of the intervention on tender nipples and swollen breasts to control confounding variables. The intervention effect is expressed as crude odds ratio and adjusted odds ratio, and the associated 95% CI will be obtained from the logistic regression model. The odds ratio was reported along with its 95% CI and was considered significantly significant statistics if the P value is <0.05.

Study Type

Interventional

Enrollment (Estimated)

100

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

  • Indonesia
    • Special Region of Yogyakarta
      • Bantul, Special Region of Yogyakarta, Indonesia, 55181
      • Bantul, Special Region of Yogyakarta, Indonesia, 55185
        • Sewon Community health centers
        • Contact:
      • Bantul, Special Region of Yogyakarta, Indonesia, 55751
      • Bantul, Special Region of Yogyakarta, Indonesia, 55781
        • Jetis community health centers
        • Contact:
      • Bantul, Special Region of Yogyakarta, Indonesia, 55791
        • Pleret Community Health Centers
        • Contact:
      • Bantul, Special Region of Yogyakarta, Indonesia, 55798

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:

  • Primigravida pregnant women who visited the Kasihan, Pajangan, Sewon, Banguntapan, Pleret, and Jetis health service centers
  • Single pregnancy
  • Mother has a mobile phone with internet access and can use WhatsApp Application
  • Plans to stay for 6 months in the research area
  • Willing to participate in the research by signing the informed consent

Exclusion Criteria:

  • Presence of congenital orofacial abnormalities (labio-gntao-palatoschisis, etc) that make breastfeeding difficult
  • Mother with breast problems (history of implant breast surgery)
  • The mother or baby experiences problems during labor or postpartum that may lead to research dropouts

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

The intervention group is third-trimester pregnant women with 34-35 weeks of gestation who received clinical demonstration education breastfeeding about position and attachment. The clinical demonstration is provided by a lactation counselor.

Respondents in this group will receive education provided face-to-face with the clinical demonstration of breastfeeding positions and attachment. The education was given twice with a duration of 40 minutes to primigravida mothers aged 34-35 weeks gestation. For outcome measurement, A home visit will be carried out by a lactation counselor and enumerator 2 times, the first home visit in 7 days postpartum and the second home visit in 14 days postpartum, to assess breastfeeding positioning and latching practices, assess the baby's sucking, evaluate nipple pain, sore nipples, and engorgement.
Behavioral: breastfeeding positions and attachment practice.
Breastfeeding clinical demonstration is a method of presentation of skills that shows how a particular procedure is performed in position and attachment breastfeeding. Respondents in this group will receive education provided face-to-face once with a duration of 40 minutes, with the following details: first, 25 minutes of education about breastfeeding position and attachment. In this case, the lactation counselor first explains the correct position and attachment for breastfeeding. Respondents were asked to carry out a practical simulation regarding the correct breastfeeding position and attachment using a doll, in this case, the lactation counselor will assess how the mother is positioned and attached. second, 10 minutes of education about swollen breasts and how to deal with them. third, a 10-minute question and answer session related to the educational material provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding positions practice
Time Frame: at birth to 14 days of postpartum
Mother's ability to practice breastfeeding positions, ordinal scale, measurement using observational checklist totalling 4 items. The value is the positions is not correct at all (if none of the criteria are met), not good positions (if 1 or 2 criteria fulfilled) and good positions (if 3 or 4 criteria fulfilled)
at birth to 14 days of postpartum
Breastfeeding attachment practice
Time Frame: at birth to 14 days of postpartum
Mother's ability to practice breastfeeding attachment, ordinal scale, measurement using observational checklist totalling 4 items. The value is the attachment is not correct at all (if none of the criteria are met), not good attachment (if 1 or 2 criteria fulfilled) and good attachment (if 3 or 4 criteria fulfilled)
at birth to 14 days of postpartum
Evaluate the baby's sucking while breastfeeding
Time Frame: at birth to 14 days of postpartum
Evaluation the baby's sucking, nominal scale, measurement using observational checklist. Correct sucking technique was defined as the infant having a wide-open mouth, with the tongue under the areola, and expressing milk from the breast by slow, deep sucks. Faulty technique was defined as superficial nipple sucking.
at birth to 14 days of postpartum
Evaluate of Sore nipples
Time Frame: at birth to 14 days of postpartum
Evaluation of sore nipples is measured by using Visuals Analog Score (VAS), ordinal scale. Scale 0 (no pain), scale 1-3 (mild), scale 4-6 (Moderate), scale 7-10 (Severe)
at birth to 14 days of postpartum
Evaluate Nipple pain
Time Frame: at birth to 14 days of postpartum
Evaluation of nipple pain is measured by Nipple Trauma Score (NTS), ordinal scale. Score 0 (no microscopically visible skin changes), score 1 (erythema or edema or combination of both), score 2 (superficial damage with or without scab formation on < 25% of the nipple surface), score 3 (superficial damage with or without scab formation on > 25% of the nipple surface), score 4 (partial-thickness wound with or without scab formation on < 25% of the nipple surface), score 5 (partial-thickness wound with or without scab formation on > 25% of the nipple surface).
at birth to 14 days of postpartum
Evaluate Engorgement
Time Frame: at birth to 14 days of postpartum
Evaluation engorgement is measured by engorgement scale, ordinal scale. Scale 1 (soft, no change), scale 2 (slight change), scale 3 (firm, non-tender), scale 4 (firm, beginning tenderness), scale 5 (firm, tender), scale 6 (very firm and very tender).
at birth to 14 days of postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge breastfeed techniques
Time Frame: 36 weeks pregnancy to 38 weeks pregnancy

Ability to give precise answers to questions regarding breastfeeding, Ordinal scale, measurement using a questionnaire totalling 18 items.

The value is poor knowledge (0-6), enough knowledge (6-12), good knowledge (13-18). The higher score means a better knowledge about breastfeed techniques.
36 weeks pregnancy to 38 weeks pregnancy

Collaborators and Investigators

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

Sponsor

Gadjah Mada University

Investigators

  • Study Director: Prasetya Lestari, M.Kes., Alma Ata University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 26, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GadjahMadaU03January2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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