ight Therapy for Treatment of Lesions of the Nipple
Phase 1
- Conditions
- Injuries to the nipple (fissures and cracks) resulting breastfeeding.F01.145.407.199
- Registration Number
- RBR-7zmz55
- Lead Sponsor
- PUC Minas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
To participate in the study, women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years.
Exclusion Criteria
Exclusion criteria was considered: previous history of cancer, use of other therapeutic modalities that might interfere with the healing of the lesions, presence of infected wounds, history of photosensitivity to light, cognitive deficits that undermine the understanding and implementation of guidelines of care for breast.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Size and classification of injuries: wounds 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.
- Secondary Outcome Measures
Name Time Method Quality of life: the impact of the presence of nipple fissures and cracks in the quality of life of the mothers will be assessed by the SF-36 (short version), applied at baseline, in the third and sixth weeks of the study.