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COMPLETED
NCT07912216
NA

Effect of Beeswax-Based Nipple Protector and Breast Milk on Nipple Problems

Sponsor: Marmara University

View on ClinicalTrials.gov

Summary

Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a safe and natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited. This study aims to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study will be conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who meet the inclusion criteria will be randomly assigned to either the intervention group, which will use a beeswax-based nipple protector, or the control group, which will receive routine breast milk application. Participants will be followed during the first 20 postpartum days. Data will be collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments will be performed at baseline and on postpartum days 10 and 20. Statistical analyses will be conducted using appropriate descriptive and comparative methods according to data distribution, and repeated measurements will be analyzed using longitudinal statistical models. This study is expected to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy.

Official title: Effect of Beeswax-Based Nipple Protector and Breast Milk on the Prevention of Nipple Problems Among Postpartum Mothers: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-06-23

Completion Date

2026-10-30

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

OTHER

Beeswax-based nipple shield

The beeswax-based nipple protector to be used in this study (MEMELYN®, Türkiye) is a commercially available product manufactured from 100% natural beeswax. Each participant allocated to the intervention group will be provided with two sterile nipple protectors. Standardized verbal instructions, practical training, and written educational materials regarding the proper use of the product will be provided. Mothers will be instructed to wash their hands after each breastfeeding session, gently dry the nipple area, and apply the nipple protector so that it completely covers the nipple and areola. The nipple protector will be recommended for continuous use between breastfeeding sessions and may be removed only during breastfeeding and bathing. The product will be reusable and participants will be instructed to clean it with warm water after each use.

OTHER

Breastmilk

Breastfeeding mothers in the control group were instructed to apply their own breast milk to their nipple areolas.Breastfeeding mothers in the control group will apply their own breast milk to their areolas. Breast assessments will be performed on days 10 and 20 using data collection tools.

Locations (1)

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)