Photobiomodulation as a New Approach for the Treatment of Nipple Traumas
October 26, 2011 updated by: Angelica Rodrigues de Araujo, Pontifícia Universidade Católica de Minas Gerais
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil
- Pontifícia Universidade Católica de Minas Gerais
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
|
|
|
EXPERIMENTAL: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
|---|---|
|
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
Outcome Measure |
Measure Description |
|---|---|
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (ACTUAL)
August 1, 2006
Study Completion (ACTUAL)
November 1, 2006
Study Registration Dates
First Submitted
October 26, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (ESTIMATE)
October 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 28, 2011
Last Update Submitted That Met QC Criteria
October 26, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 0239.0.213.000-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.