Laser Therapy in Nipples Injured During Breastfeeding

NCT ID: NCT01723995

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-07-31

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.

Conditions

Nipple Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

low-level laser on nipples

Intervention Type: RADIATION

The LASER HAND WL device, manufactured by MM Optics.

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).

Group Type: PLACEBO_COMPARATOR

low-level laser on nipples

Intervention Type: RADIATION

The LASER HAND WL device, manufactured by MM Optics.

Interventions

low-level laser on nipples

The LASER HAND WL device, manufactured by MM Optics.

Intervention Type: RADIATION

Other Intervention 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)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Kelly Pereira Coca

PhD student - Nurse midwife

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly P. Coca, MD

Role: PRINCIPAL_INVESTIGATOR

Student - Federal University of Sao Paulo

Ana CV Abrão, PHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Monica A. Gamba, PHD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo - Sao Paulo School of Nursing

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CEP 1710-9

Identifier Type: -

Identifier Source: org_study_id