Photobiomodulation as a New Approach for the Treatment of Nipple Traumas
|Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding||Device: Photobiomodulation||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Size and classification of injurieswounds nipple will be measured weekly in the initial assessment and for six consecutive weeks, using a digital caliper and classified at the beginning and end of treatment according to Pereira et al (1998). The measurements and classification of cracks will be conducted by a researcher previously trained to perform procedures.
- Pain:pain intensity will be evaluated using the Visual Numeric Scale (VNS). The EVN will be applied at baseline and at the beginning of each week of treatment, for six consecutive weeks.
|Study Start Date:||February 2006|
|Study Completion Date:||November 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
|No Intervention: Control|
the participants of this group will receive, in addition to guidance on the breast care and proper techniques for feeding, phototherapy applications through photobiomodulador a device developed specifically for the treatment of nipple injuries. The parameters for applications are: continuous mode of emission, power output 10 mW, wavelength infrared (scanning from 880 to 904 nm) fluence of 4 J / cm ² and total application time of 10 minutes.
The application of the device will be three times per week on alternate days for seven consecutive weeks, totaling 21 sessions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462019
|Pontifícia Universidade Católica de Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil|