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.
Radiation: low-level laser on nipples
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Locations near you
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Full eligibility criteria for NCT01723995
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Women hospitalized in the Accommodation System with their children, feeding exclusively directly from the breast and presenting unilateral or bilateral nipple trauma.
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.
All locations for NCT01723995
Federal University of Sao Paulo - Sao Paulo School of Nursing
Sao Paulo, Brazil, 04024-002
View full eligibility
Tris trial is registered with FDA with number: NCT01723995. The sponsor of the trial is Federal University of São Paulo and it is looking for 66 volunteers for the current phase.
Official trial title: Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding
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