xml: <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/NCT05992753</url>
    </required_header>
    <id_info>
      <org_study_id>1</org_study_id>
      <nct_id>NCT05992753</nct_id>
    </id_info>
    <brief_title>Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels</brief_title>
    <official_title>Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels in the Early Postpartum Period: A Cross-sectional Study in Turkish Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Halic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Istanbul Arel University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Basaksehir Cam &amp; Sakura Şehir Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Halic University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Expressing breast milk in cases where breastfeeding is interrupted is important&#xD;
        for infants to be fed breast milk however, many factors can affect mothers' breastfeeding&#xD;
        experience, such as feeding attitudes and the level of social support. The aim of this study&#xD;
        is to determine the relationship mothers' breast milk expression experience between infant&#xD;
        feeding attitudes and perceived social support level.&#xD;
  &#xD;
        Methods: This cross-sectional study was carried out in the postpartum and lactation unit of a&#xD;
        city hospital in Istanbul, between September-November 2022. The study included 455 women who&#xD;
        were volunteering to participate in the research, 18 years of age or older, in the 0-6 months&#xD;
        postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk&#xD;
        at least once after birth. Data were collected with Mother-Baby Introductory Information&#xD;
        Form, Breast Milk Expression Experience Measure (BMEE), Iowa Infant Feeding Attitude Scale&#xD;
        (IIFAS), and Multidimensional Scale of Perceived Social Support (MSPSS). The data were&#xD;
        analyzed using the SPSS-21 statistical software package.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Which characteristics affect mothers' breast milk expression experiences, infant feeding&#xD;
             attitudes, and perceived social support levels in the early postpartum period?&#xD;
  &#xD;
          -  Is there a relationship between mothers' experiences of breast milk expression and their&#xD;
             infant feeding attitudes and social support levels in the early postpartum period?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">January 5, 2023</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mother-Baby Introductory Information Form</measure>
      <time_frame>September 1st - November 30th 2022</time_frame>
      <description>The form prepared by the researchers consists of 25 questions containing information about the mother, the infant, and the nutrition characteristics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Breast Milk Expression Experience Measure (BMEE)</measure>
      <time_frame>September 1st - November 30th 2022</time_frame>
      <description>The BMEE, which was developed to determine the breast milk expression experience of mothers, consists of 11 items. The BMEE is a five-point Likert type, ranging from one (strongly disagree) to five (strongly agree). It has three sub-dimensions: social support, learning experience, and personal experience. When the mean of the total items' score is less than three, the breast milk expression experience of the mothers is evaluated as negative.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iowa Infant Feeding Attitude Scale (IIFAS)</measure>
      <time_frame>September 1st - November 30th 2022</time_frame>
      <description>The scale was designed to evaluate women's attitudes towards breastfeeding and predict the duration of breastfeeding as well as the choice of infant feeding method. IIFAS consists of 17 items and is a five-point Likert type (one-strongly disagree to five-strongly agree). While nine items of the IIFAS contain positive attitudes about breastfeeding, the other eight items contain positive attitudes about formula feeding. The total IIFAS score can range from 17 to 85, with higher scores reflecting a positive attitude towards breastfeeding. Total IIFAS scores can be categorized into three groups: positive to breastfeeding (IIFAS score 70-85), neutral (IIFAS score 49-69), and positive to formula feeding (IIFAS score 17-48).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multidimensional Scale of Perceived Social Support (MSPSS)</measure>
      <time_frame>September 1st - November 30th 2022</time_frame>
      <description>MSPSS subjectively assesses the adequacy of social support from three different sources (family, friends, and a significant other), consists of 12 items, and is a seven-point Likert type (one-very strongly disagree to seven-very strongly agree). The lowest score to be obtained from MSPSS is 12, and the highest score is 84. The higher the total score, the higher the perceived social support.</description>
    </primary_outcome>
    <enrollment type="Actual">455</enrollment>
    <condition>Breastfeeding</condition>
    <condition>Breast Milk Expression</condition>
    <condition>Feeding Behavior</condition>
    <condition>Support, Family</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire application</intervention_name>
      <description>The research data were collected from 455 mothers admitted to the postpartum and lactation unit of a city hospital in Istanbul between September and November 2022. The mothers to be included in the study sample were determined according to the non-probability sampling method, considering the inclusion criteria of the study. The research data were collected by the researchers face-to-face through a questionnaire that lasted about 10-20 minutes.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The research population consisted of women who were admitted to the postpartum and&#xD;
          lactation units of a city hospital in Istanbul affiliated with the Turkish Ministry of&#xD;
          Health. A power analysis was performed to determine the number of people to be included in&#xD;
          the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteer to participate in the research&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  In the 0-6 month postpartum period&#xD;
  &#xD;
            -  Must have a living baby&#xD;
  &#xD;
            -  Must continue breastfeeding&#xD;
  &#xD;
            -  Must express breast milk at least once after birth&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Feeding the infant formula only&#xD;
  &#xD;
            -  Having hearing and/or speech impairments&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Halic University</name>
        <address>
          <city>Istanbul</city>
          <zip>34060</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992753
  org study id: 1
  nct id: NCT05992753
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Expressing breast milk in cases where breastfeeding is interrupted is important
        for infants to be fed breast milk however, many factors can affect mothers' breastfeeding
        experience, such as feeding attitudes and the level of social support. The aim of this study
        is to determine the relationship mothers' breast milk expression experience between infant
        feeding attitudes and perceived social support level.
  
        Methods: This cross-sectional study was carried out in the postpartum and lactation unit of a
        city hospital in Istanbul, between September-November 2022. The study included 455 women who
        were volunteering to participate in the research, 18 years of age or older, in the 0-6 months
        postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk
        at least once after birth. Data were collected with Mother-Baby Introductory Information
        Form, Breast Milk Expression Experience Measure (BMEE), Iowa Infant Feeding Attitude Scale
        (IIFAS), and Multidimensional Scale of Perceived Social Support (MSPSS). The data were
        analyzed using the SPSS-21 statistical software package.
  
        The main questions it aims to answer are:
  
          -  Which characteristics affect mothers' breast milk expression experiences, infant feeding
             attitudes, and perceived social support levels in the early postpartum period?
  
          -  Is there a relationship between mothers' experiences of breast milk expression and their
             infant feeding attitudes and social support levels in the early postpartum period?
  observational model: Other
  time perspective: Cross-Sectional
  measure: Mother-Baby Introductory Information Form
  time frame: September 1st - November 30th 2022
  description: The form prepared by the researchers consists of 25 questions containing information about the mother, the infant, and the nutrition characteristics.
  measure: Breast Milk Expression Experience Measure (BMEE)
  time frame: September 1st - November 30th 2022
  description: The BMEE, which was developed to determine the breast milk expression experience of mothers, consists of 11 items. The BMEE is a five-point Likert type, ranging from one (strongly disagree) to five (strongly agree). It has three sub-dimensions: social support, learning experience, and personal experience. When the mean of the total items' score is less than three, the breast milk expression experience of the mothers is evaluated as negative.
  measure: Iowa Infant Feeding Attitude Scale (IIFAS)
  time frame: September 1st - November 30th 2022
  description: The scale was designed to evaluate women's attitudes towards breastfeeding and predict the duration of breastfeeding as well as the choice of infant feeding method. IIFAS consists of 17 items and is a five-point Likert type (one-strongly disagree to five-strongly agree). While nine items of the IIFAS contain positive attitudes about breastfeeding, the other eight items contain positive attitudes about formula feeding. The total IIFAS score can range from 17 to 85, with higher scores reflecting a positive attitude towards breastfeeding. Total IIFAS scores can be categorized into three groups: positive to breastfeeding (IIFAS score 70-85), neutral (IIFAS score 49-69), and positive to formula feeding (IIFAS score 17-48).
  measure: Multidimensional Scale of Perceived Social Support (MSPSS)
  time frame: September 1st - November 30th 2022
  description: MSPSS subjectively assesses the adequacy of social support from three different sources (family, friends, and a significant other), consists of 12 items, and is a seven-point Likert type (one-very strongly disagree to seven-very strongly agree). The lowest score to be obtained from MSPSS is 12, and the highest score is 84. The higher the total score, the higher the perceived social support.
  intervention type: Other
  intervention name: Questionnaire application
  description: The research data were collected from 455 mothers admitted to the postpartum and lactation unit of a city hospital in Istanbul between September and November 2022. The mothers to be included in the study sample were determined according to the non-probability sampling method, considering the inclusion criteria of the study. The research data were collected by the researchers face-to-face through a questionnaire that lasted about 10-20 minutes.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Sponsor
  sharing ipd: No