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Completed

NCT Number: NCT01723995

Laser Therapy in Nipples Injured During Breastfeeding

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo - Sao Paulo School of Nursing

São Paulo, 04024-002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low-level laser on nipples

Radiation

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding

Acronym: LTNIBF

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Nov 8, 2012
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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