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/NCT06009120</url>
    </required_header>
    <id_info>
      <org_study_id>Eyşan Hanzade Savaş</org_study_id>
      <nct_id>NCT06009120</nct_id>
    </id_info>
    <brief_title>Psychosexual Development Theory-Based Breastfeeding Education</brief_title>
    <official_title>Impact of Psychosexual Development Theory-Based Breastfeeding Education on Infant Feeding Attitudes and Knowledge of Primiparous Mothers: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koç University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Koç 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>
        Breastfeeding education based on the theory of psychosexual development is important as it&#xD;
        addresses the social and psychological significance of childhood and the impact of early&#xD;
        childhood experiences on later social anxieties and psychosexual well-being. However, no&#xD;
        theory-based breastfeeding education given to the mothers was found in the literature.&#xD;
        Therefore, the study aimed to investigate the effect of breastfeeding education on infant&#xD;
        feeding attitudes and knowledge of primiparous mothers, in line with the theory of&#xD;
        psychosocial development.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breastfeeding is known to play a health-enhancing and disease-preventive role for both the&#xD;
        mother and the baby. While it is recognized to reduce postpartum blood loss in mothers and&#xD;
        provide protection against conditions like depression, Type 2 diabetes, hypertension, and&#xD;
        breast &amp; ovarian cancer; for infants, it is noted that breastfeeding offers protection&#xD;
        against many infectious diseases due to the antibodies it, reduces sudden infant deaths and&#xD;
        decreases mortality under the age of five [6]. However, despite these benefits, breastfeeding&#xD;
        rates have not yet reached desired levels in many countries today.&#xD;
  &#xD;
        The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend&#xD;
        that during the first six months, infants should be exclusively breastfed, avoiding the use&#xD;
        of water, other liquids, supplementary foods/formula, and solid foods.In our country,&#xD;
        according to the Turkey Demographic and Health Survey 2018 data, the rate of exclusive&#xD;
        breastfeeding during the first six months is 41%. Among these mothers, it has been determined&#xD;
        that 41.7% of them provide their babies with additional liquids/foods other than breast milk&#xD;
        within the first three days after birth. Contrary to recommendations, the use of additional&#xD;
        liquids/foods in the early days increases the risk of discontinuing breastfeeding before six&#xD;
        months by threefold.&#xD;
  &#xD;
        Regardless of medical reasons, the main reasons for the consumption of supplementary&#xD;
        foods/formula in the early days include the baby's frequent hunger cues and the mother's&#xD;
        concern that her milk might not be sufficient. Additionally, the physiological weight loss&#xD;
        that newborns experience in the first few days after birth further supports and amplifies&#xD;
        mothers' concerns of &quot;not having enough milk.&quot; After the 3rd to 5th day following birth, as&#xD;
        milk production advances in the mother's body, the subsequent process involves milk becoming&#xD;
        fattier and the baby beginning to gain weight. Therefore, it is crucial for mothers to be&#xD;
        properly informed about this process, including the baby's behaviors and the content of the&#xD;
        milk.&#xD;
  &#xD;
        In addition to these physiological changes, Freud has developed a theory on psychosexual&#xD;
        development. At the core of the theory lies a pleasurable pursuit for bodily sensations and&#xD;
        control. The period from birth to one year of age is referred to as the &quot;Oral Stage&quot; in that&#xD;
        theory. During this period, it is emphasized that the newborn starts to explore the world&#xD;
        orally and derives satisfaction/pleasure from sucking behavior. Examples of this are finger&#xD;
        sucking, pacifier use, and the behavior of putting any object they hold into their mouth,&#xD;
        commonly observed in babies. These are typical processes of a healthy newborn and a&#xD;
        developing baby within the context of psychosexual development over time. Hence, infants can&#xD;
        exhibit hunger cues not only to satisfy their hunger but also for the purpose of experiencing&#xD;
        pleasure. However, no study in the literature has directly correlated this information with&#xD;
        newborn-sucking behavior. Current research underscores the need for effective interventions&#xD;
        with proper timing and highlights that primiparous mothers tend to have greater concerns&#xD;
        about insufficient milk than multiparous mothers. Proper guidance and information about&#xD;
        physiological processes are crucial for acquiring breastfeeding behavior. In this study, in&#xD;
        line with Freud's psychosexual development theory, the impact of breastfeeding education&#xD;
        provided after childbirth on primiparous mothers' feeding attitudes and behaviors has been&#xD;
        investigated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</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>
      <intervention_model_description>Patients who met the sample selection criteria were randomly divided into two groups, an intervention (education) group and a CG, using a computer-based program (www.random.org). The assignment to the intervention and CG was performed by an independent statistician. Thus, by implementing randomized allocation and concealing the randomization, selection bias was controlled. In the study, participant blinding was carried out, but researcher blinding was not possible due to the researcher's awareness of the intervention being administered. In a 1:1 ratio, the women were separated into intervention and CGs (Figure 1).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>IOWA Infant Feeding Attitude Scale</measure>
      <time_frame>1 WEEK</time_frame>
      <description>The scale was developed by De La Mora et al. in 1999 to assess the attitudes of women towards breastfeeding and to predict the choice of infant feeding method as well as the duration of breastfeeding. The total attitude score ranges from 17 (indicating a positive attitude towards bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Breastfeeding Form</measure>
      <time_frame>1 WEEK</time_frame>
      <description>This form was created by the researchers to evaluate the mothers' experiences of breastfeeding and using formula for one week after birth. The form includes four questions about breastfeeding frequency &amp; duration and formula use &amp; frequency from day to day.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Breastfeeding</condition>
    <condition>Psychosocial Development</condition>
    <condition>Nursing Caries</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention (education) group:&#xD;
  In addition to the standard discharge education, mothers in this group received breastfeeding education.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group: In this group, first of all, mothers were informed about the study within the first day after birth, and informed consent forms were signed by those who voluntarily agreed to participate. In addition, &quot;Personal Information Form&quot;, &quot;IOWA Infant Feeding Attitude Scale&quot; and &quot;Psychosexual Theory and Breastfeeding Information Scale&quot; were applied to these mothers on the first day. Then, as the routine care of the institution, the standard discharge education program on the third day was applied by the institution nurse. After this education, &quot;IOWA Infant Feeding Attitude Scale&quot; and &quot;Psychosexual Theory and Breastfeeding Knowledge Form&quot; were re-administered to mothers as a post-test. No additional intervention was applied other than standard care education. During the 5 days following discharge, mothers were interviewed by phone and &quot;Breastfeeding Form'' applied.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Education</intervention_name>
      <description>The education program emphasized the characteristics of the oral stage, positive traits that can be acquired when the baby's needs are met during this stage, negative traits that may develop in the baby when their needs are not met, and the relationship between the oral stage and breastfeeding.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being primitive,&#xD;
  &#xD;
            -  being 18 years or older,&#xD;
  &#xD;
            -  having a healthy birth,&#xD;
  &#xD;
            -  using a mobile phone,&#xD;
  &#xD;
            -  being within 72-96 hours after birth,&#xD;
  &#xD;
            -  participating in the research voluntarily.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having cognitive problems,&#xD;
  &#xD;
            -  delivering a premature newborn, having a baby in the neonatal intensive care unit,&#xD;
  &#xD;
            -  having a health problem that would prevent her from breastfeeding the baby,&#xD;
  &#xD;
            -  using any sedatives, anticonvulsants, or analgesics, don't the ability to speak&#xD;
               Turkish,&#xD;
  &#xD;
            -  giving formula to their baby for any reason within the first three days,&#xD;
  &#xD;
            -  having a life-threatening illness or condition,&#xD;
  &#xD;
            -  not being willing to participate in the study will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The study was carried out with mothers who gave birth, so women were studied.</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eyşan Hanzade UMAÇ</last_name>
      <role>Principal Investigator</role>
      <affiliation>Koç University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Koc University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Koç University</investigator_affiliation>
      <investigator_full_name>Eysan Hanzade Umac</investigator_full_name>
      <investigator_title>Teaching Assistant</investigator_title>
    </responsible_party>
    <!-- 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/NCT06009120
  org study id: Eyşan Hanzade Savaş
  nct id: NCT06009120
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breastfeeding education based on the theory of psychosexual development is important as it
        addresses the social and psychological significance of childhood and the impact of early
        childhood experiences on later social anxieties and psychosexual well-being. However, no
        theory-based breastfeeding education given to the mothers was found in the literature.
        Therefore, the study aimed to investigate the effect of breastfeeding education on infant
        feeding attitudes and knowledge of primiparous mothers, in line with the theory of
        psychosocial development.
  Breastfeeding is known to play a health-enhancing and disease-preventive role for both the
        mother and the baby. While it is recognized to reduce postpartum blood loss in mothers and
        provide protection against conditions like depression, Type 2 diabetes, hypertension, and
        breast & ovarian cancer; for infants, it is noted that breastfeeding offers protection
        against many infectious diseases due to the antibodies it, reduces sudden infant deaths and
        decreases mortality under the age of five [6]. However, despite these benefits, breastfeeding
        rates have not yet reached desired levels in many countries today.
  
        The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend
        that during the first six months, infants should be exclusively breastfed, avoiding the use
        of water, other liquids, supplementary foods/formula, and solid foods.In our country,
        according to the Turkey Demographic and Health Survey 2018 data, the rate of exclusive
        breastfeeding during the first six months is 41%. Among these mothers, it has been determined
        that 41.7% of them provide their babies with additional liquids/foods other than breast milk
        within the first three days after birth. Contrary to recommendations, the use of additional
        liquids/foods in the early days increases the risk of discontinuing breastfeeding before six
        months by threefold.
  
        Regardless of medical reasons, the main reasons for the consumption of supplementary
        foods/formula in the early days include the baby's frequent hunger cues and the mother's
        concern that her milk might not be sufficient. Additionally, the physiological weight loss
        that newborns experience in the first few days after birth further supports and amplifies
        mothers' concerns of "not having enough milk." After the 3rd to 5th day following birth, as
        milk production advances in the mother's body, the subsequent process involves milk becoming
        fattier and the baby beginning to gain weight. Therefore, it is crucial for mothers to be
        properly informed about this process, including the baby's behaviors and the content of the
        milk.
  
        In addition to these physiological changes, Freud has developed a theory on psychosexual
        development. At the core of the theory lies a pleasurable pursuit for bodily sensations and
        control. The period from birth to one year of age is referred to as the "Oral Stage" in that
        theory. During this period, it is emphasized that the newborn starts to explore the world
        orally and derives satisfaction/pleasure from sucking behavior. Examples of this are finger
        sucking, pacifier use, and the behavior of putting any object they hold into their mouth,
        commonly observed in babies. These are typical processes of a healthy newborn and a
        developing baby within the context of psychosexual development over time. Hence, infants can
        exhibit hunger cues not only to satisfy their hunger but also for the purpose of experiencing
        pleasure. However, no study in the literature has directly correlated this information with
        newborn-sucking behavior. Current research underscores the need for effective interventions
        with proper timing and highlights that primiparous mothers tend to have greater concerns
        about insufficient milk than multiparous mothers. Proper guidance and information about
        physiological processes are crucial for acquiring breastfeeding behavior. In this study, in
        line with Freud's psychosexual development theory, the impact of breastfeeding education
        provided after childbirth on primiparous mothers' feeding attitudes and behaviors has been
        investigated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients who met the sample selection criteria were randomly divided into two groups, an intervention (education) group and a CG, using a computer-based program (www.random.org). The assignment to the intervention and CG was performed by an independent statistician. Thus, by implementing randomized allocation and concealing the randomization, selection bias was controlled. In the study, participant blinding was carried out, but researcher blinding was not possible due to the researcher's awareness of the intervention being administered. In a 1:1 ratio, the women were separated into intervention and CGs (Figure 1).
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: IOWA Infant Feeding Attitude Scale
  time frame: 1 WEEK
  description: The scale was developed by De La Mora et al. in 1999 to assess the attitudes of women towards breastfeeding and to predict the choice of infant feeding method as well as the duration of breastfeeding. The total attitude score ranges from 17 (indicating a positive attitude towards bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).
  measure: Breastfeeding Form
  time frame: 1 WEEK
  description: This form was created by the researchers to evaluate the mothers' experiences of breastfeeding and using formula for one week after birth. The form includes four questions about breastfeeding frequency & duration and formula use & frequency from day to day.
  arm group label: Intervention
  arm group type: Experimental
  description: Intervention (education) group:
  In addition to the standard discharge education, mothers in this group received breastfeeding education.
  arm group label: Control
  arm group type: No Intervention
  description: Control group: In this group, first of all, mothers were informed about the study within the first day after birth, and informed consent forms were signed by those who voluntarily agreed to participate. In addition, "Personal Information Form", "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Information Scale" were applied to these mothers on the first day. Then, as the routine care of the institution, the standard discharge education program on the third day was applied by the institution nurse. After this education, "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Knowledge Form" were re-administered to mothers as a post-test. No additional intervention was applied other than standard care education. During the 5 days following discharge, mothers were interviewed by phone and "Breastfeeding Form'' applied.
  intervention type: Other
  intervention name: Education
  description: The education program emphasized the characteristics of the oral stage, positive traits that can be acquired when the baby's needs are met during this stage, negative traits that may develop in the baby when their needs are not met, and the relationship between the oral stage and breastfeeding.
  arm group label: Intervention
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The study was carried out with mothers who gave birth, so women were studied.
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eyşan Hanzade UMAÇ
  role: Principal Investigator
  affiliation: Koç University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Koç University
  investigator full name: Eysan Hanzade Umac
  investigator title: Teaching Assistant