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The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack

Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04259320
Enrollment
90
Registered
2020-02-06
Start date
2020-02-17
Completion date
2020-11-30
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Cracked Nipple in Puerperium

Brief summary

In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing barrier and breast milk used in the first ten days of breastfeeding to prevent the formation of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women. Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no treatment-control).

Detailed description

Current evidence-based guidelines report that the incidence of nipple cracks ranges between 34-96%. Nipple cracks generally occur in the first week after the birth and may continue in the following periods of breastfeeding. Nipple crack is the second most common reason to stop breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies has been expressed as extremely painful and terrible. It is known that breast milk, olive oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks, will successfully allow to continue breastfeeding. In this way, breastfeeding will not be interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months. Using non-pharmacological, effective and therapeutic methods will also have a positive effect to increase the rate of breastfeeding. Studies in the literature cover the evaluation of the effectiveness of beeswax or beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an effective and sufficient material in preventing and healing nipple cracks. In this study, it is planned to include 90 lactating women (30 women in each group) to meet the parametric test assumptions in the experimental and control groups (beeswax-containing barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the experimental and control groups will be randomized.

Interventions

DEVICEBeeswax containing barrier

Use beeswax containing barrier on each nipple after each breastfeeding.

BIOLOGICALBreast milk

Apply breast milk on each nipple and areola after each breastfeeding.

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
Karabuk Training and Research Hospital
CollaboratorOTHER
Karabuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Being over 18 years old; * Normal spontaneous delivery. * Pregnancy weeks between 37-42. * Single birth. * Initiated breastfeeding. * Having given birth to a healthy, full-term child. * Newborn with no oral, palatal or maxillofacial abnormalities. * Not taking any medication, considering that drug use may cause nipple problems. * Being able to read and write. * Volunteering to participate in the study. * Not having contraindications for breastfeeding.

Exclusion criteria

* Not approving to participate in the research. * Being a multipara. * Not breastfeeding within the first 24 hours. * Development of any breast problem: Mastitis, engorgement etc. * Taking newborn into intensive care. * Not sticking to the application. * Using another nipple crack preventing method during application. * Being allergic to beeswax.

Design outcomes

Primary

MeasureTime frameDescription
Nipple crack changeChange from baseline nipple crack at 10 daysUse Nipple Crack score 0-3 (Nipple cracks increase as the score increases)

Secondary

MeasureTime frameDescription
Severity of nipple pain changeChange from baseline severity of nipple pain at 10 days.Use Numeric Rating Scale 0-10 point (The severity of pain increases as the score increases)

Other

MeasureTime frameDescription
Presence of nipple pain changeChange from baseline presence of nipple pain at 10 days.Questionary (Yes/No)
Maternal satisfactionBaseline from baseline nipple crack at 10 daysQuestionary (Use the satisfaction categories-likert)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026