Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

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.

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Key information

Conditions

Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Device

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.

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Pontifícia Universidade Católica de Minas Gerais

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Oct 28, 2011
Registry last updated: Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed