We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01462019
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
Angelica Rodrigues de Araujo, 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.

Condition or disease Intervention/treatment Phase
Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding Device: Photobiomodulation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2006
Primary Completion Date : August 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Photobiomodulation Device: Photobiomodulation

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 Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462019

Pontifícia Universidade Católica de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Pontifícia Universidade Católica de Minas Gerais

Responsible Party: Angelica Rodrigues de Araujo, Profa., Phd, Pontifícia Universidade Católica de Minas Gerais
ClinicalTrials.gov Identifier: NCT01462019     History of Changes
Other Study ID Numbers: 0239.0.213.000-07
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

Keywords provided by Angelica Rodrigues de Araujo, Pontifícia Universidade Católica de Minas Gerais:
nipple trauma
breast feeding
wound healing