Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women
Condition: Breastfeeding
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in
      Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast
      feeding at the maternity ward and developed symptoms of painful and sore nipples within 72
      hours from childbirth. Participants will be allocated in two groups and will receive
      education prior to the study.
    

Detailed description: 
      Recent studies show that early termination of breastfeeding is often associated with painful
      and sore nipples. Although health professionals recommend various treatments for painful and
      sore nipples, including alternative treatments, there is currently not enough evidence to
      recommend specific treatment of painful and sore nipples in lactating women. The primary
      objective of this study is to compare the effect of lanolin administration and the
      application of breast milk on the intensity of pain and healing of damaged nipples during
      breastfeeding. Subjects in the lanolin group will apply lanolin on each nipple and areola
      after each feeding while subjects in the breast milk group will apply several drops of milk
      on the nipple after each feed and allow them to air dry. In both groups, the treatment will
      last for 7 days or until the symptoms of pain and nipple damage have ceased. The main outcome
      measure is pain, which will be assessed through three time points and will be measured using
      an abridged version of the McGill Pain Questionnaire. Nipple damage will be assessed by means
      of a validated assessment tool, the Nipple trauma score. Secondary outcome measures will
      include breastfeeding efficacy, duration of any/exclusive breastfeeding, reasons for stopping
      breastfeeding and satisfaction with proposed treatment.The contribution of this study will be
      reflected in efficient treatment, better care of health professional in the prevention and
      treatment of damaged and sore nipples, and the study will also contribute in defining the
      guidelines for the development of procedure in midwifery practice for the treatment of
      painful and damaged nipples.
    

Intervention name(s): Lanolin; Mother's milk
Intervention type(s): Drug; Other
Intervention description(s): Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).; After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention