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Completed

NCT Number: NCT04259320

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

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).

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karabuk University Training and Research Hospital

Karabük, Merkez, 07780, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beeswax containing barrier

Device

Use beeswax containing barrier on each nipple after each breastfeeding.

Breast milk

Biological

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. Presence of nipple pain change

    Time frame: Change from baseline presence of nipple pain at 10 days.

    Questionary (Yes/No)

  2. Maternal satisfaction

    Time frame: Baseline from baseline nipple crack at 10 days

    Questionary (Use the satisfaction categories-likert)

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Collaborators

  • Istanbul University - Cerrahpasa
  • Karabuk Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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