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NCT Number: NCT06770595

Breastfeeding Education Through Clinical Demonstration 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.

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Key information

Conditions

Nipple Infection Behavior Breast Diseases Breast Feeding Cardiovascular Diseases Engorgement Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Galactorrhea Hyperemia Lactation Disorders Nipple Discharge Pregnancy Complications Puerperal Disorders Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Vascular Diseases

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banguntapan community health centers, Bantul, Special Region of Yogyakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding positions and attachment practice.

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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)

  5. 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).

  6. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eka Nurhayati, Dr

CONTACT

[email protected]

+6285740022890

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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