An interventional study of breastfeeding positions and attachment practice. in Nipple Infection, Nipple Discharge and Engorgement, sponsored by Gadjah Mada University. Not yet recruiting at 6 sites in Indonesia. Open to female participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Gadjah Mada University · Not applicable, Interventional, and Other
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.
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.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 68 across 51 interventional studies indexed under Hyperemia.
Browse Hyperemia studies →Gadjah Mada University is the lead sponsor of 63 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Breastfeeding positions practice
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)
Time frame: at birth to 14 days of postpartum
Breastfeeding attachment practice
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)
Time frame: at birth to 14 days of postpartum
Evaluate the baby's sucking while breastfeeding
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.
Time frame: at birth to 14 days of postpartum
Evaluate of Sore nipples
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)
Time frame: at birth to 14 days of postpartum
Evaluate Nipple pain
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).
Time frame: at birth to 14 days of postpartum
Evaluate Engorgement
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).
Time frame: at birth to 14 days of postpartum
Change in knowledge breastfeed techniques
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.
Time frame: 36 weeks pregnancy to 38 weeks pregnancy
Plan to share: No
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Gadjah Mada University