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/NCT05962866</url>
    </required_header>
    <id_info>
      <org_study_id>Ataturk University SSAHIN0003</org_study_id>
      <nct_id>NCT05962866</nct_id>
    </id_info>
    <brief_title>The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role&quot;</brief_title>
    <official_title>&quot;I and II Pregnant Women Under Midwife Supervision. The Effect of Leopold Maneuvers on Pregnancy Distress and Maternal Role Perception&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sibel ÖZTÜRK</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        The role of motherhood; Motherhood can be defined as a learning process that includes&#xD;
        knowledge, skills, attitudes and behaviors of a woman who has been handed down from&#xD;
        generation to generation. Mother-infant attachment; At the behavioral and emotional level, it&#xD;
        is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body&#xD;
        changes, her uterus expands and the mother begins to feel fetal movements. The fact that&#xD;
        women adopt the role of motherhood throughout pregnancy is very important for attachment&#xD;
        behaviors and infant attachment patterns in the early and late postpartum period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is very important for midwives to implement and teach the interventions that will enable&#xD;
        pregnant women to take an active role in this period, in terms of perception of the role of&#xD;
        motherhood and pregnancy distress. . The literature provides a data source for leopard&#xD;
        maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on&#xD;
        pregnancy distress and the perception of maternal role. This study, which is planned to&#xD;
        support and develop awareness in this area, is important in terms of literature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>statistician</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Measuring pregnancy distress of pregnant women</measure>
      <time_frame>two months</time_frame>
      <description>The Cronbach Alpha value of the scale was found to be 0.83. The scale, which can be applied to pregnant women who are twelve weeks and older, consists of 16 items and is graded as a 4-point Likert scale. The total score that can be obtained from the scale ranges from 0 to 48. A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress. The scale has 2 sub-dimensions as &quot;negative affect&quot; consisting of 11 items and &quot;partner participation&quot; consisting of 5 items. Items 1, 2, 4, 8 and 15 in the scale belong to peer involvement, other items belong to negative affect.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measuring pregnant women's perception of maternal role</measure>
      <time_frame>two months</time_frame>
      <description>The internal consistency reliability of the scale was found to be between 0.81-0.85. The validity and reliability study of the scale was adapted to Turkish society by Çalışır The scale consists of 11 semantic opposite adjective pairs with 22 items and seven points, which analyze the concept of Me as a Mother. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to avoid the possibility of bias while the participant was answering the questions. Items 3, 7 and 8 were evaluated over 1 point instead of 7 points. The lowest score is 11 and the highest score is 77. High total scores from the scale indicate positive motherhood self-assessment. The Cronbach Alpha reliability coefficient of the Semantic Difference Scale-Me as a Mother scale was determined as 0.73-0.74.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Mother-Child Relations</condition>
    <arm_group>
      <arm_group_label>Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Voluntary information form will be read to those who want to participate in the research, verbal and written permissions will be obtained and information will be given about fetal development and Leopold maneuvers in the pregnant follow-up room of the family health center. This transaction is 28-32. 32-38 at the next follow-up at gestational weeks. Pregnancy will be carried out with the same procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control: Assigned Interventions standard care group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be made.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>I and II. Performing Leopold Maneuvers by the pregnant</intervention_name>
      <description>24-32 and 32-38 days of pregnancy by the pregnant woman. 1st and 2nd leoppold maneuvers are performed by the pregnant woman, 2 times between weeks.</description>
      <arm_group_label>Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Spontaneous single pregnancy,&#xD;
  &#xD;
            -  28th gestational week,&#xD;
  &#xD;
            -  Over the age of 18, under the age of 40,&#xD;
  &#xD;
            -  Not having communication difficulties and mental disabilities, Literate,&#xD;
  &#xD;
            -  Not having any chronic health problems (hypertension, heart disease,&#xD;
  &#xD;
            -  obesity etc.)&#xD;
  &#xD;
            -  Does not have a psychiatric disease and does not use psychiatric drugs, Exclusion&#xD;
               Criteria&#xD;
  &#xD;
            -  Not open to communication and cooperation during the working period,&#xD;
  &#xD;
            -  Reluctant to participate in the research,&#xD;
  &#xD;
            -  Not completing the questionnaires,&#xD;
  &#xD;
            -  Pregnant women who gave birth prematurely were not included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>being pregnant</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Songül Kekil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muş Hasköy Family Health Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sibel Öztürk, Asst. Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Ataturk University Faculty of Health Sciences Department of Midwifery</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Songül Kekil</last_name>
      <phone>05445482460</phone>
      <email>kekilsongul@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sibel Öztürk, Asst. Prof.</last_name>
      <phone>05357951648</phone>
      <email>sibelc-06@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Muş Hasköy Family Health Center</name>
        <address>
          <city>Muş</city>
          <zip>49700</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>İsmail Arslan, Dr.</last_name>
        <phone>05398651570</phone>
      </contact>
      <contact_backup>
        <last_name>Ender Kızılkale, Dr.</last_name>
        <phone>05315508201</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Sibel ÖZTÜRK</investigator_full_name>
      <investigator_title>Asst. Prof.</investigator_title>
    </responsible_party>
    <keyword>Leopold maneuver</keyword>
    <keyword>pregnancy</keyword>
    <keyword>midwifery</keyword>
    <keyword>fetus</keyword>
    <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/NCT05962866
  org study id: Ataturk University SSAHIN0003
  nct id: NCT05962866
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The role of motherhood; Motherhood can be defined as a learning process that includes
        knowledge, skills, attitudes and behaviors of a woman who has been handed down from
        generation to generation. Mother-infant attachment; At the behavioral and emotional level, it
        is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body
        changes, her uterus expands and the mother begins to feel fetal movements. The fact that
        women adopt the role of motherhood throughout pregnancy is very important for attachment
        behaviors and infant attachment patterns in the early and late postpartum period.
  It is very important for midwives to implement and teach the interventions that will enable
        pregnant women to take an active role in this period, in terms of perception of the role of
        motherhood and pregnancy distress. . The literature provides a data source for leopard
        maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on
        pregnancy distress and the perception of maternal role. This study, which is planned to
        support and develop awareness in this area, is important in terms of literature.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: statistician
  measure: Measuring pregnancy distress of pregnant women
  time frame: two months
  description: The Cronbach Alpha value of the scale was found to be 0.83. The scale, which can be applied to pregnant women who are twelve weeks and older, consists of 16 items and is graded as a 4-point Likert scale. The total score that can be obtained from the scale ranges from 0 to 48. A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress. The scale has 2 sub-dimensions as "negative affect" consisting of 11 items and "partner participation" consisting of 5 items. Items 1, 2, 4, 8 and 15 in the scale belong to peer involvement, other items belong to negative affect.
  measure: Measuring pregnant women's perception of maternal role
  time frame: two months
  description: The internal consistency reliability of the scale was found to be between 0.81-0.85. The validity and reliability study of the scale was adapted to Turkish society by Çalışır The scale consists of 11 semantic opposite adjective pairs with 22 items and seven points, which analyze the concept of Me as a Mother. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to avoid the possibility of bias while the participant was answering the questions. Items 3, 7 and 8 were evaluated over 1 point instead of 7 points. The lowest score is 11 and the highest score is 77. High total scores from the scale indicate positive motherhood self-assessment. The Cronbach Alpha reliability coefficient of the Semantic Difference Scale-Me as a Mother scale was determined as 0.73-0.74.
  arm group label: Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers
  arm group type: Experimental
  description: Voluntary information form will be read to those who want to participate in the research, verbal and written permissions will be obtained and information will be given about fetal development and Leopold maneuvers in the pregnant follow-up room of the family health center. This transaction is 28-32. 32-38 at the next follow-up at gestational weeks. Pregnancy will be carried out with the same procedure.
  arm group label: Control: Assigned Interventions standard care group
  arm group type: No Intervention
  description: No intervention will be made.
  intervention type: Other
  intervention name: I and II. Performing Leopold Maneuvers by the pregnant
  description: 24-32 and 32-38 days of pregnancy by the pregnant woman. 1st and 2nd leoppold maneuvers are performed by the pregnant woman, 2 times between weeks.
  arm group label: Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers
  criteria: 
  gender: Female
  gender based: Yes
  gender description: being pregnant
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Songül Kekil
  role: Principal Investigator
  affiliation: Muş Hasköy Family Health Center
  last name: Sibel Öztürk, Asst. Prof.
  role: Study Director
  affiliation: Ataturk University Faculty of Health Sciences Department of Midwifery
  last name: Songül Kekil
  phone: 05445482460
  email: kekilsongul@gmail.com
  last name: Sibel Öztürk, Asst. Prof.
  phone: 05357951648
  email: sibelc-06@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ataturk University
  investigator full name: Sibel ÖZTÜRK
  investigator title: Asst. Prof.
  sharing ipd: No