Laser Therapy in Nipples Injured During Breastfeeding

Nipple Trauma Clinical Trial

— LTNIBF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723995
• Other study ID #: CEP 1710-9
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: February 23, 2018
• Start date: February 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nipple Trauma

Intervention

Radiation:
• low-level laser on nipples
The LASER HAND WL device, manufactured by MM Optics.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Sao Paulo School of Nursing	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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