Development of a randomized controlled trial to compare different strength/whatever low intensity laser irradiation in the management of nipple pain for breastfeeding women with nipple damage

Abstract

Introduction: The nipple lesion is an ancient barrier to the continuity of breastfeeding, considered as one of the main causes of early weaning. The low intensity laser can be considered as a coadjuvant in the treatment of these lesions, as it provides analgesia, anti-inflammatory effect and stimulates tissue repair. Goals: To develop an randomized clinical trial protocol based on the current studies of different low intensity laser dosimetry in the management of nipple pain in women with nipple lesions during breastfeeding. Material and Method: Development of an randomized clinical trial protocol in which the Standard dose for the control group and other doses for the treatment groups to be tested will be defined, based on the literature studies and results of the investigations carried out by our group until now. The dosage that will be applied to the laser, the parameters of evaluation of nipple pain and lesion and the variables for inclusion in the protocol (parity, skin characteristic and nipple type) will be defined to homogenize the sample in the comparison of the groups. The study will be submitted to the Research Ethics Committee and registered with the Autralian New Zealand Clinical Trials Registry. The developed protocol will be applied in a study in Brazil, after the end of the postdoctoral period, in two maternity hospitals of São Paulo. Outcome Analysis: The protocol will follow the Consort 2010 guidelines for randomized clinical trials. Expected Results: The result of the protocol will contribute to the definition of the best fluency of the low power laser in the nipples during the breastfeeding phase, currently considered as a promising adjuvant therapy in the management of nipple damage. (AU)