Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nipple fissure
研究概览
简要总结
Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain.
详细描述
Nipple fissures are the second major cause of the discontinuation of breastfeeding, following a sensation of insufficient milk, which leads to bottle feeding. Poor positioning of the child in relation to the breast, an inadequate frequency or duration of breastfeeding and improper suckling are the main causes of nipple fissure. Discontinuing breastfeeding deprives the infant of essential nutrients and also deprives the mother of certain health benefits. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures.
The aim of this study is to evaluate LED therapy in treatment of nipple fissures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistic analysis
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nursing mothers aged 18 years or older
- •Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales
- •Having given birth to a healthy, full-term child
- •Performing exclusive breastfeeding
- •Newborn with no oral, palatal or maxillofacial abnormalities
- •Newborn weighing between 2500 and 4000 grams
排除标准
- •History of psychological disorder
- •Presence of mastitis
- •Bacterial or fungal infection in breasts
- •Use of breast pump or plastic nipple
研究组 & 干预措施
Led Therapy
The following will be the phototherapeutic parameters: total spot area: 1.44 cm²; continuous emission mode; output power: 10 mW; infrared wavelength (880 to 904 nm); fluence: 4 J/cm²; and application time: 10 minutes/session. Sessions will be held three times a week on alternating days for six consecutive weeks, totaling 18 sessions.
干预措施: Led Therapy (Device)
Control
The control group will receive orientation regarding breast care and adequate breastfeeding techniques. The experimental group will receive the same orientation plus phototherapy sessions using a device developed especially for the treatment of nipple trauma. Both groups will be followed up for six consecutive weeks.
结局指标
主要结局
Nipple fissure
时间窗: 1 week
Nipple fissure will be evaluate with digital calipers - Black Bull Scale
次要结局
未报告次要终点
研究者
Lara Jansiski Motta
Principal Investigator
University of Nove de Julho