Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Change in nipple pain severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Participants will be randomly assigned to two study groups. An envelope containing a note, "mother's milk group" or "lanolin group" will be randomly distributed among women by a midwife who is not a part of the study. The participants will know which group they belong to. A single blind masking will be used during telephone data collection on day three and seven of treatment.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
- •Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
- •Access to telephone
- •Signed Informed consent
排除标准
- •Primiparas with mental disorders
- •Mothers allergy to lanolin
- •Mothers with abnormal nipples
- •Breast hypoplasia
- •Infant with cleft palate
- •Ankyloglossia
- •Unsigned Informed consent
研究组 & 干预措施
Lanolin
干预措施: Lanolin (Drug)
Mother's milk
干预措施: Mother's milk (Other)
结局指标
主要结局
Change in nipple pain severity
时间窗: baseline, 3 and 7 days post randomization
An abbreviated version of the McGill Questionnaire (SF-MPQ) will be used to assess the intensity of nipple pain. For the assessment of the current intensity of pain in the nipples will be used subcategories SF-MPQ, the current assessment of pain (PPI). It consists of a verbal scoring scale with values from 0 to 5, 0= No pain, 1= Mild, 2 = Discomforting, 3= Distressing, 4= Horrible, 5= Excruciating
Nipple damage change
时间窗: baseline, 3 and 7 days post randomization
The baseline assessment of nipple damage will be performed by a validated Nipple Trauma Score (NST). The assessment is performed on scales from 0 to 5 where 0 = no macroscopically visible changes in the skin, 1 = erythema or edema or a combination of both, 2 = superficial damage or no scab on \<25% of the nipple surface, 3 = superficial damage with or without scab on\> 25% of nipple surface, 4 = partial thickness wound with or without scab on \<25% of nipple surface, 5 = partial thickness with or without scab on\> 25% of nipple surface. Three and 7 days after applying the treatment, the condition of the nipple will be evaluated with a Questionnaire on Pain and Damage to the Nipple, where a telephone survey will be performed by the Principal Investigator in order to describe and compare the condition of the nipples.
次要结局
- Breastfeeding duration and exclusivity.(3 and 7 days post randomization, 3 and 6 months postpartum)
- Satisfaction with proposed treatment(3 and 6 months postpartum)
- Assessment of breastfeeding self-efficacy(baseline, 3 and 7 days post randomization)
研究者
Olivera Perić
Olivera Perić MSc, Head nurse Department of Gynecology and Obstetrics
University of Mostar