Laser Therapy in Nipples Injured During Breastfeeding

Study Overview
=================
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.

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.

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

Conditions
-----------------
Nipple Trauma

Intervention / Treatment
-----------------
* Radiation: low-level laser on nipples


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-level laser on nipples<br>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<br>* The LASER HAND WL device, manufactured by MM Optics.<br>* Other names: with emission of continuous light (CW);|
| Placebo Comparator: low-level laser off on nipples<br>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). | Radiation: low-level laser on nipples<br>* The LASER HAND WL device, manufactured by MM Optics.<br>* Other names: with emission of continuous light (CW);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of nipple pain during breastfeeding | 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. | Time - between 12 and 60 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue repair in nipples during breastfeeding | Secondarily, the nipple wound characteristics shall be assessed regarding tissue repair with the use of laser, compared to the control group. | Between 12 and 60 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nipple/injure, breastfeeding, pain, laser