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临床试验/NCT01723995
NCT01723995已完成不适用

Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Reduction of nipple pain during breastfeeding

研究概览

简要总结

This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in mothers with nipple trauma during breastfeeding, compared to a control group.

详细描述

The selection was made through the search of women hospitalized in Accommodation beds with nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon acceptance and signing of the consent form. To collect the data, a group was formed with people trained as evaluators, responsible for election, randomization, filling of First Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation before and after treatment with laser; and applicators, responsible for laser handling and irradiation. Data collection followed the following order: filling of the first instrument, breast image capture, suckling observation, identification of pain during the child's breast sucking, laser irradiation and re-identification of pain during the child's breast sucking after laser treatment. The collection of data of this form occurred continuously every twelve hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum of six assessments were carried out, from the inclusion of the patient in the study (taken as zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during the same period, including one to three irradiations per patient in each of the breasts.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma.

排除标准

  • Women who were using any other form of treatment for nipple trauma; use of any topical substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple; presence of mastitis; previous history or presence of malignancies; presence of photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for the first day of data collection; women under unfavorable psycho-affective and cognitive situations which prevented assessment of the analog pain scale, photo image record. and observation of breastfeeding; women who had twins, children with gestational age less than 37 weeks, or birth weight less than 2500 grams.

研究组 & 干预措施

low-level laser on nipples

Experimental

Application of laser light from the device in direct contact with the nipple injury, equipment connected and set up at a dose of 5J/cm2 (Epoint = 0.2J/cm2) for both groups, three consecutive doses of 5J/cm2 (ETotal = 0.6J/cm2) along the entire length of the injury.

干预措施: low-level laser on nipples (Radiation)

low-level laser off on nipples

Placebo Comparator

Laser with modified standard operation - shutdown of InGaAIP semiconductor diode and installation of a visible red light emitting diode with optical power of 0mW (LED - Light Emitting Diode - maximum power with standard nozzle).

干预措施: low-level laser on nipples (Radiation)

结局指标

主要结局

Reduction of nipple pain during breastfeeding

时间窗: Time - between 12 and 60 hours

The mothers treated with low-level laser therapy should present a decrease in the degree of pain during breastfeeding in the presence of nipple trauma compared to the control group.

次要结局

  • Tissue repair in nipples during breastfeeding(Between 12 and 60 hours)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Pereira Coca

PhD student - Nurse midwife

Federal University of São Paulo

研究点 (2)

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