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Laser Therapy in Nipples Injured During Breastfeeding (LTNIBF)

Primary Purpose

Nipple Trauma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
low-level laser on nipples
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nipple Trauma focused on measuring nipple/injure, breastfeeding, pain, laser

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Sao Paulo - Sao Paulo School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

low-level laser on nipples

low-level laser off on nipples

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2012
Last Updated
February 23, 2018
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01723995
Brief Title
Laser Therapy in Nipples Injured During Breastfeeding
Acronym
LTNIBF
Official Title
Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nipple Trauma
Keywords
nipple/injure, breastfeeding, pain, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-level laser on nipples
Arm Type
Experimental
Arm Description
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.
Arm Title
low-level laser off on nipples
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
low-level laser on nipples
Other Intervention Name(s)
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)
Intervention Description
The LASER HAND WL device, manufactured by MM Optics.
Primary Outcome Measure Information:
Title
Reduction of nipple pain during breastfeeding
Description
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 Frame
Time - between 12 and 60 hours
Secondary Outcome Measure Information:
Title
Tissue repair in nipples during breastfeeding
Description
Secondarily, the nipple wound characteristics shall be assessed regarding tissue repair with the use of laser, compared to the control group.
Time Frame
Between 12 and 60 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly P. Coca, MD
Organizational Affiliation
Student - Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana CV Abrão, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica A. Gamba, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo - Sao Paulo School of Nursing
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

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Laser Therapy in Nipples Injured During Breastfeeding

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