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

NCT06770595 | Not Yet Recruiting

• 1 other identifier: GadjahMadaU03January2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Nipple Infection; Nipple Discharge; Engorgement

Keywords

Demonstration clinic; Education; Sore nipples; Engorgement; Breastfeeding

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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.

  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)

  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).

  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).

  at birth to 14 days of postpartum

Secondary Outcomes (1)

• Change in knowledge breastfeed techniques

  36 weeks pregnancy to 38 weeks pregnancy

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (6)

Kasihan Community Health Centers

Bantul, Special Region of Yogyakarta, 55181, Indonesia

Location

Sewon Community health centers

Bantul, Special Region of Yogyakarta, 55185, Indonesia

Location

Pajangan Community Health Centers

Bantul, Special Region of Yogyakarta, 55751, Indonesia

Location

Jetis community health centers

Bantul, Special Region of Yogyakarta, 55781, Indonesia

Location

Pleret Community Health Centers

Bantul, Special Region of Yogyakarta, 55791, Indonesia

Location

Banguntapan community health centers

Bantul, Special Region of Yogyakarta, 55798, Indonesia

Location

Related Publications (12)

• 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.

  PMID: 16106316 BACKGROUND

• 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.

  PMID: 24057589 RESULT

• 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.

  PMID: 12727395 RESULT

• 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.

  PMID: 14768311 RESULT

• 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.

  PMID: 31080479 RESULT

• 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.

  PMID: 29804762 RESULT

• 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.

  PMID: 20576199 RESULT

• 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.

  PMID: 26426034 RESULT

• 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.

  PMID: 26591707 RESULT

• 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.

  PMID: 24304033 RESULT

• 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.

  PMID: 24062375 RESULT

• 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.

  PMID: 32944940 RESULT

MeSH Terms

Conditions

Galactorrhea; Hyperemia; Breast Feeding

Condition Hierarchy (Ancestors)

Lactation Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Feeding Behavior; Behavior

Study Officials

• Prasetya Lestari, M.Kes.

  Alma Ata University

  STUDY DIRECTOR

Central Study Contacts

Eka Nurhayati, Dr

CONTACT

+6285740022890; ekanhayati@almaata.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Eka Nurhayati, S.ST., M.K.M

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: December 26, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (6)