<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723995</url>
  </required_header>
  <id_info>
    <org_study_id>CEP 1710-9</org_study_id>
    <nct_id>NCT01723995</nct_id>
  </id_info>
  <brief_title>Laser Therapy in Nipples Injured During Breastfeeding</brief_title>
  <acronym>LTNIBF</acronym>
  <official_title>Effect of Low-level of Laser Therapy in Nipple Trauma During Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in&#xD;
      mothers with nipple trauma during breastfeeding, compared to a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The selection was made through the search of women hospitalized in Accommodation beds with&#xD;
      nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon&#xD;
      acceptance and signing of the consent form. To collect the data, a group was formed with&#xD;
      people trained as evaluators, responsible for election, randomization, filling of First&#xD;
      Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation&#xD;
      before and after treatment with laser; and applicators, responsible for laser handling and&#xD;
      irradiation. Data collection followed the following order: filling of the first instrument,&#xD;
      breast image capture, suckling observation, identification of pain during the child's breast&#xD;
      sucking, laser irradiation and re-identification of pain during the child's breast sucking&#xD;
      after laser treatment. The collection of data of this form occurred continuously every twelve&#xD;
      hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum&#xD;
      of six assessments were carried out, from the inclusion of the patient in the study (taken as&#xD;
      zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during&#xD;
      the same period, including one to three irradiations per patient in each of the breasts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of nipple pain during breastfeeding</measure>
    <time_frame>Time - between 12 and 60 hours</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue repair in nipples during breastfeeding</measure>
    <time_frame>Between 12 and 60 hours</time_frame>
    <description>Secondarily, the nipple wound characteristics shall be assessed regarding tissue repair with the use of laser, compared to the control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Nipple Trauma</condition>
  <arm_group>
    <arm_group_label>low-level laser on nipples</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low-level laser off on nipples</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>low-level laser on nipples</intervention_name>
    <description>The LASER HAND WL device, manufactured by MM Optics.</description>
    <arm_group_label>low-level laser off on nipples</arm_group_label>
    <arm_group_label>low-level laser on nipples</arm_group_label>
    <other_name>LASER HAND WL InGaAIP semicondutor</other_name>
    <other_name>registered by ANVISA/MS No. 80051420009</other_name>
    <other_name>wavelength 660 nn</other_name>
    <other_name>Optical power 40mW</other_name>
    <other_name>visible red spectrum range</other_name>
    <other_name>with emission of continuous light (CW)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women hospitalized in the Accommodation System with their children, feeding exclusively&#xD;
        directly from the breast and presenting unilateral or bilateral nipple trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women who were using any other form of treatment for nipple trauma; use of any topical&#xD;
        substance in the nipple-areola region; presence of inverted and pseudo-inverted nipple;&#xD;
        presence of mastitis; previous history or presence of malignancies; presence of&#xD;
        photosensitivity or any adverse reactions to exposure to sunlight; discharge planned for&#xD;
        the first day of data collection; women under unfavorable psycho-affective and cognitive&#xD;
        situations which prevented assessment of the analog pain scale, photo image record. and&#xD;
        observation of breastfeeding; women who had twins, children with gestational age less than&#xD;
        37 weeks, or birth weight less than 2500 grams.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly P. Coca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Student - Federal University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana CV Abrão, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Monica A. Gamba, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Sao Paulo - Sao Paulo School of Nursing</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>February 23, 2018</last_update_submitted>
  <last_update_submitted_qc>February 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Kelly Pereira Coca</investigator_full_name>
    <investigator_title>PhD student - Nurse midwife</investigator_title>
  </responsible_party>
  <keyword>nipple/injure</keyword>
  <keyword>breastfeeding</keyword>
  <keyword>pain</keyword>
  <keyword>laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723995
org study id: CEP 1710-9
nct id: NCT01723995
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction of nipple pain during breastfeeding
time frame: Time - between 12 and 60 hours
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.
measure: Tissue repair in nipples during breastfeeding
time frame: Between 12 and 60 hours
description: Secondarily, the nipple wound characteristics shall be assessed regarding tissue repair with the use of laser, compared to the control group.
arm group label: low-level laser on nipples
arm group type: Experimental
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 group label: low-level laser off on nipples
arm group type: Placebo Comparator
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: low-level laser on nipples
description: The LASER HAND WL device, manufactured by MM Optics.
arm group label: low-level laser off on nipples
arm group label: low-level laser on nipples
other name: LASER HAND WL InGaAIP semicondutor
other name: registered by ANVISA/MS No. 80051420009
other name: wavelength 660 nn
other name: Optical power 40mW
other name: visible red spectrum range
other name: with emission of continuous light (CW)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Kelly P. Coca, MD
role: Principal Investigator
affiliation: Student - Federal University of Sao Paulo
last name: Ana CV Abrão, PHD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
last name: Monica A. Gamba, PHD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Kelly Pereira Coca
investigator title: PhD student - Nurse midwife
mesh term: Wounds and Injuries