Light therapy for treatment of lesions of the nipple

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7zmz55
• Date of registration: 03/07/2011
• Primary sponsor: PUC Minas - Brazil
• Public title: Light therapy for treatment of lesions of the nipple
• Scientific title: Photobiomodulation as a new approach for the treatmment of nipple traumas: a pilot study
• Target sample size: 10
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7zmz55/
• Study design: Clinical trial (pilot study), randomized, phase 1-2, with two arms.

Countries of recruitment

Brazil

Contacts

• Name: Angélica Araújo
• Affiliation: PUC Minas

• Name: Angélica Araújo
• Affiliation: PUC Minas

Key inclusion & exclusion criteria

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.

Age minimum: 18Y
Age maximum: 35Y
Gender: F

Health Condition(s) or Problem(s) studied

Injuries to the nipple (fissures and cracks) resulting breastfeeding
F01.145.407.199

Intervention(s)

Participants will be randomly assigned to one of two treatment groups: control or experimental. The control group will receive guidance on breastfeeding and the experimental group will receive, in addition, applications of phototherapy.
Control group (orientation): the participants of this group receive individual guidance on the care and proper techniques for breast feeding. The information will be passed verbally and reinforced by an educational brochure on initial assessment, the third and sixth weeks of the study, always by the same professional, blind to treatment group the participant.
Experimental group (orientation, light therapy): the participants of this group will receive, in addition to guidance on the breast care and proper techniques for feeding, phototherapy applications through fotobiomodulador 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.

Primary Outcome(s)

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.

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.

Secondary Outcome(s)

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.

Secondary ID(s)

CAAE 0130.0.213.000-05