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

October 17, 2021 updated by: Seda Serhatlioglu, Karabuk University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Karabük, Merkez, Turkey, 07780
        • Karabük University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beeswax containing barrier
Beeswax containing barrier will be given to the breastfeeding mother within the first 24 hours. After breastfeeding, it can be placed on the breast after it is expected to dry a little.Outside of breastfeeding and bathing, it will be constantly attached to the breasts.
Device: Beeswax containing barrier
Use beeswax containing barrier on each nipple after each breastfeeding.
Experimental: Breast milk
After breastfeeding, 2-3 drops of breast milk are applied to the nipple and areola. After the milk has dried, the breasts are closed. This application should be done at least 5 times a day.
Biological: Breast milk
Apply breast milk on each nipple and areola after each breastfeeding.
No Intervention: No treatment- control
It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nipple crack change
Time Frame: Change from baseline nipple crack at 10 days
Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases)
Change from baseline nipple crack at 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of nipple pain change
Time Frame: Change 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)
Change from baseline severity of nipple pain at 10 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of nipple pain change
Time Frame: Change from baseline presence of nipple pain at 10 days.
Questionary (Yes/No)
Change from baseline presence of nipple pain at 10 days.
Maternal satisfaction
Time Frame: Baseline from baseline nipple crack at 10 days
Questionary (Use the satisfaction categories-likert)
Baseline from baseline nipple crack at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karabuk University

Collaborators

Istanbul University - Cerrahpasa (IUC)
Karabuk Training and Research Hospital

Investigators

  • Study Director: Sibel Mutlu, OB/GYN, Karabuk University Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • E-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After begin to study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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