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

NCT ID: NCT06770595

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-26

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nipple Infection Nipple Discharge Engorgement

Keywords

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Demonstration clinic Education Sore nipples Engorgement Breastfeeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

breastfeeding positions and attachment practice.

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Eka Nurhayati

Dr. Eka Nurhayati, S.ST., M.K.M

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prasetya Lestari, M.Kes.

Role: STUDY_DIRECTOR

Alma Ata University

Locations

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Kasihan Community Health Centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Sewon Community health centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Pajangan Community Health Centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Jetis community health centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Pleret Community Health Centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Banguntapan community health centers

Bantul, Special Region of Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Eka Nurhayati, Dr

Role: CONTACT

Phone: +6285740022890

Email: [email protected]

Facility Contacts

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Arantika Meidya Pratiwi, M.Kes.

Role: primary

Fatimatasarii, M. Keb.

Role: primary

Annisa Nurmasari, Amd. Keb.

Role: primary

Ratih Devi Alfiana, M.Keb.

Role: primary

Isti Chana Zuliyati, M. Keb.

Role: primary

Lisana Shidiq Aliya, MPH

Role: primary

References

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Weigert EM, Giugliani ER, Franca MC, Oliveira LD, Bonilha A, Espirito Santo LC, Kohler CV. [The influence of breastfeeding technique on the frequencies of exclusive breastfeeding and nipple trauma in the first month of lactation]. J Pediatr (Rio J). 2005 Jul-Aug;81(4):310-6. Portuguese.

Reference Type BACKGROUND
PMID: 16106316 (View on PubMed)

Bergmann RL, Bergmann KE, von Weizsacker K, Berns M, Henrich W, Dudenhausen JW. Breastfeeding is natural but not always easy: intervention for common medical problems of breastfeeding mothers - a review of the scientific evidence. J Perinat Med. 2014 Jan;42(1):9-18. doi: 10.1515/jpm-2013-0095.

Reference Type RESULT
PMID: 24057589 (View on PubMed)

Bhandari N, Bahl R, Mazumdar S, Martines J, Black RE, Bhan MK; Infant Feeding Study Group. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth: a cluster randomised controlled trial. Lancet. 2003 Apr 26;361(9367):1418-23. doi: 10.1016/S0140-6736(03)13134-0.

Reference Type RESULT
PMID: 12727395 (View on PubMed)

Blair A, Cadwell K, Turner-Maffei C, Brimdyr K. The relationship between positioning, the breastfeeding dynamic, the latching process and pain in breastfeeding mothers with sore nipples. Breastfeed Rev. 2003 Jul;11(2):5-10.

Reference Type RESULT
PMID: 14768311 (View on PubMed)

Degefa N, Tariku B, Bancha T, Amana G, Hajo A, Kusse Y, Zerihun E, Aschalew Z. Breast Feeding Practice: Positioning and Attachment during Breast Feeding among Lactating Mothers Visiting Health Facility in Areka Town, Southern Ethiopia. Int J Pediatr. 2019 Apr 7;2019:8969432. doi: 10.1155/2019/8969432. eCollection 2019.

Reference Type RESULT
PMID: 31080479 (View on PubMed)

Feenstra MM, Jorgine Kirkeby M, Thygesen M, Danbjorg DB, Kronborg H. Early breastfeeding problems: A mixed method study of mothers' experiences. Sex Reprod Healthc. 2018 Jun;16:167-174. doi: 10.1016/j.srhc.2018.04.003. Epub 2018 Apr 6.

Reference Type RESULT
PMID: 29804762 (View on PubMed)

Haggkvist AP, Brantsaeter AL, Grjibovski AM, Helsing E, Meltzer HM, Haugen M. Prevalence of breast-feeding in the Norwegian Mother and Child Cohort Study and health service-related correlates of cessation of full breast-feeding. Public Health Nutr. 2010 Dec;13(12):2076-86. doi: 10.1017/S1368980010001771. Epub 2010 Jun 25.

Reference Type RESULT
PMID: 20576199 (View on PubMed)

Kent JC, Ashton E, Hardwick CM, Rowan MK, Chia ES, Fairclough KA, Menon LL, Scott C, Mather-McCaw G, Navarro K, Geddes DT. Nipple Pain in Breastfeeding Mothers: Incidence, Causes and Treatments. Int J Environ Res Public Health. 2015 Sep 29;12(10):12247-63. doi: 10.3390/ijerph121012247.

Reference Type RESULT
PMID: 26426034 (View on PubMed)

Safari JG, Kimambo SC, Lwelamira JE. Feeding practices and nutritional status of infants in Morogoro Municipality, Tanzania. Tanzan J Health Res. 2013 Jul;15(3):178-85. doi: 10.4314/thrb.v15i3.5.

Reference Type RESULT
PMID: 26591707 (View on PubMed)

Teich AS, Barnett J, Bonuck K. Women's perceptions of breastfeeding barriers in early postpartum period: a qualitative analysis nested in two randomized controlled trials. Breastfeed Med. 2014 Jan-Feb;9(1):9-15. doi: 10.1089/bfm.2013.0063. Epub 2013 Dec 4.

Reference Type RESULT
PMID: 24304033 (View on PubMed)

Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.

Reference Type RESULT
PMID: 24062375 (View on PubMed)

Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.

Reference Type RESULT
PMID: 32944940 (View on PubMed)

Other Identifiers

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GadjahMadaU03January2025

Identifier Type: -

Identifier Source: org_study_id