Laser Therapy in Nipples Injured During Breastfeeding (LTNIBF)
|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
|Condition or disease||Intervention/treatment|
|Nipple Trauma||Radiation: low-level laser on nipples|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723995
|Contact: Kelly P. Coca, research||55 11 9 email@example.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 firstname.lastname@example.org|
|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|