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Laser Therapy in Nipples Injured During Breastfeeding (LTNIBF)

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ClinicalTrials.gov Identifier: NCT01723995
Recruitment Status : Unknown
Verified October 2012 by Kelly Pereira Coca, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Information provided by (Responsible Party):
Kelly Pereira Coca, Federal University of São Paulo

Brief Summary:
This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in mothers with nipple trauma during breastfeeding, compared to a control group.

Condition or disease Intervention/treatment
Nipple Trauma Radiation: low-level laser on nipples

Detailed Description:
The selection was made through the search of women hospitalized in Accommodation beds with nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon acceptance and signing of the consent form. To collect the data, a group was formed with people trained as evaluators, responsible for election, randomization, filling of First Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation before and after treatment with laser; and applicators, responsible for laser handling and irradiation. Data collection followed the following order: filling of the first instrument, breast image capture, suckling observation, identification of pain during the child's breast sucking, laser irradiation and re-identification of pain during the child's breast sucking after laser treatment. The collection of data of this form occurred continuously every twelve hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum of six assessments were carried out, from the inclusion of the patient in the study (taken as zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during the same period, including one to three irradiations per patient in each of the breasts.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding
Study Start Date : February 2011
Primary Completion Date : November 2011
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: low-level laser on nipples
Application of laser light from the device in direct contact with the nipple injury, equipment connected and set up at a dose of 5J/cm2 (Epoint = 0.2J/cm2) for both groups, three consecutive doses of 5J/cm2 (ETotal = 0.6J/cm2) along the entire length of the injury.
Radiation: low-level laser on nipples
The LASER HAND WL device, manufactured by MM Optics.
Other Names:
  • LASER HAND WL InGaAIP semicondutor
  • registered by ANVISA/MS No. 80051420009
  • wavelength 660 nn
  • Optical power 40mW
  • visible red spectrum range
  • with emission of continuous light (CW)
Placebo Comparator: low-level laser off on nipples
Laser with modified standard operation - shutdown of InGaAIP semiconductor diode and installation of a visible red light emitting diode with optical power of 0mW (LED - Light Emitting Diode - maximum power with standard nozzle).

Primary Outcome Measures :
  1. Reduction of nipple pain during breastfeeding [ Time Frame: Time - between 12 and 60 hours ]
    The mothers treated with low-level laser therapy should present a decrease in the degree of pain during breastfeeding in the presence of nipple trauma compared to the control group.

Secondary Outcome Measures :
  1. Tissue repair in nipples during breastfeeding [ Time Frame: Between 12 and 60 hours ]
    Secondarily, the nipple wound characteristics shall be assessed regarding tissue repair with the use of laser, compared to the control group.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma.

Exclusion Criteria:

Women who were using any other form of treatment for nipple trauma; use of any topical substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple; presence of mastitis; previous history or presence of malignancies; presence of photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for the first day of data collection; women under unfavorable psycho-affective and cognitive situations which prevented assessment of the analog pain scale, photo image record. and observation of breastfeeding; women who had twins, children with gestational age less than 37 weeks, or birth weight less than 2500 grams.

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): NCT01723995

Contact: Kelly P. Coca, research 55 11 9 9909-1256 kcocaepm@hotmail.com

Federal University of Sao Paulo - Sao Paulo School of Nursing Recruiting
Sao Paulo, Brazil, 04024-002
Contact: Kelly P. Coca, MD    55 11 9909-1256    kcocaepm@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Kelly P. Coca, MD Student - Federal University of Sao Paulo
Principal Investigator: Ana CV Abrão, PHD Federal University of Sao Paulo
Principal Investigator: Monica A. Gamba, PHD Federal University of Sao Paulo

Responsible Party: Kelly Pereira Coca, PhD student - Obstetrical nurse, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01723995     History of Changes
Other Study ID Numbers: CEP 1710-9
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: October 2012

Keywords provided by Kelly Pereira Coca, Federal University of São Paulo: