Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

Phase 1

Completed

• Conditions: Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding
• Interventions: Device: Photobiomodulation

• Registration Number: NCT01462019
• Lead Sponsor: Pontifícia Universidade Católica de Minas Gerais

Brief Summary

Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the breast and the appropriate techniques for breastfeeding. These measures, however, have a much more preventive than curative, it is not, in most cases, sufficient to power the closing of nipple trauma. The objective of this study was to evaluate the effectiveness of a phototherapy device designed specifically for the treatment of nipple trauma.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-08
• Study Completion: 2006-11
• Status Verified: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-26
• Last Update Submitted: 2011-10-26
• Study First Posted: 2011-10-28
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years

Exclusion Criteria

• 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: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation	Photobiomodulation	-

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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pontifícia Universidade Católica de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil