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/NCT05976776</url>
    </required_header>
    <id_info>
      <org_study_id>Amasya Un</org_study_id>
      <nct_id>NCT05976776</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas</brief_title>
    <official_title>Effectiveness of a Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Amasya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Amasya 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>
        To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal&#xD;
        Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of&#xD;
        148 pregnant women are planned to be included in the study. Data will be collected with the&#xD;
        'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety&#xD;
        Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The &quot;Childbirth and Parenthood&#xD;
        Preparation Education&quot; program will be applied to the experimental group for a period of four&#xD;
        weeks (a month (each week, once a week in total four sessions)). It is thought that the&#xD;
        results of the research will contribute to the welfare of pregnant women by reducing maternal&#xD;
        health needs, pregnancy-related anxiety and fetal health anxiety levels.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal&#xD;
        Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of&#xD;
        148 pregnant women are planned to be included in the study. Data will be collected with the&#xD;
        'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety&#xD;
        Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The &quot;Childbirth and Parenthood&#xD;
        Preparation Education&quot; program will be applied to the experimental group for a period of four&#xD;
        weeks (a month (each week, once a week in total four sessions)). Within the scope of the&#xD;
        &quot;Childbirth and Parenthood Preparation training&quot; program; Physiological and psychological&#xD;
        changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and&#xD;
        substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support&#xD;
        during pregnancy, pregnancy follow-ups, routine examinations and immunization, common&#xD;
        problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and&#xD;
        what to do, risky pregnancies, drug and human medicinal product management during pregnancy,&#xD;
        labor process, drug-free methods for coping with labor pain, postpartum period and its&#xD;
        characteristics, physiological changes in the mother after birth, psychological changes in&#xD;
        puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the&#xD;
        postpartum period, postpartum contraception methods will be explained. It is thought that the&#xD;
        results of the research will contribute to the welfare of pregnant women by reducing maternal&#xD;
        health needs, pregnancy-related anxiety and fetal health anxiety levels.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 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>
      <intervention_model_description>A randomized-controlled trial with pretest-posttest control group</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Levels of Maternal Health Needs</measure>
      <time_frame>1 months</time_frame>
      <description>Maternal Health Needs is one of the primary outcomes. This will be measured using 'Maternal Health Needs Scale (MHNS) '. The minimum score that can be obtained from the scale is &quot;23&quot;, the maximum score is &quot;115&quot;, and as the scale score increases, maternal health needs also increase.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pregnancy-Related Anxiety Levels</measure>
      <time_frame>1 months</time_frame>
      <description>Pregnancy related anxiety level is another outcomes. This will be mesured using &quot;Pregnancy-Related Anxiety Scale- Revision 2&quot;. The minimum score that can be obtained from the scale is &quot;11&quot;, the maximum score is &quot;55&quot;, as the score obtained from the scale increases, the level of anxiety in pregnancy also increases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fetal Health Anxiety Levels</measure>
      <time_frame>1 months</time_frame>
      <description>Fetal Health Anxiety level is another outcomes. This will be mesured using &quot;Fetal Health Anxiety Inventory (FHAI)&quot;. The minimum score that can be obtained from the scale is &quot;0&quot;, the maximum score is &quot;42&quot;, as the total score from the scale increases, the level of fetal health anxiety increases.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">148</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Childbirth and Parenthood Preparation Education program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Childbirth and Parenthood Preparation Education</intervention_name>
      <description>The &quot;Childbirth and Parenthood Preparation Education&quot; program will be applied to the experimental group for a period of 1 month (each week, once a week in total four sessions).</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Literate&#xD;
  &#xD;
            -  18-40 years old&#xD;
  &#xD;
            -  Primigravida&#xD;
  &#xD;
            -  Those who volunteered to participate in the research&#xD;
  &#xD;
            -  Pregnant women who do not have communication and mental difficulties&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who do not fill out the entire questionnaire&#xD;
  &#xD;
            -  Those with risky pregnancy&#xD;
  &#xD;
            -  Pregnant women with a previous history of psychiatric illness&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Pregnant women</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>Emine İbici Akça</last_name>
      <role>Principal Investigator</role>
      <affiliation>Amasya University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emine İbici Akça, Ph.D</last_name>
      <phone>03582115005-4723</phone>
      <email>emine.akca@amasya.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Amasya University</name>
        <address>
          <city>Amasya</city>
          <zip>05100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Amasya University</investigator_affiliation>
      <investigator_full_name>Emine Akca</investigator_full_name>
      <investigator_title>Assist. Prof. Dr. in the Amasya University Midwifery Department</investigator_title>
    </responsible_party>
    <keyword>Maternal Health Needs</keyword>
    <keyword>Fetal Health Anxiety</keyword>
    <keyword>Primiparous women</keyword>
    <keyword>Childbirth and Parenthood Preparation Education</keyword>
    <keyword>Pregnancy-Related Anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <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/NCT05976776
  org study id: Amasya Un
  nct id: NCT05976776
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal
        Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of
        148 pregnant women are planned to be included in the study. Data will be collected with the
        'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety
        Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood
        Preparation Education" program will be applied to the experimental group for a period of four
        weeks (a month (each week, once a week in total four sessions)). It is thought that the
        results of the research will contribute to the welfare of pregnant women by reducing maternal
        health needs, pregnancy-related anxiety and fetal health anxiety levels.
  To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal
        Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of
        148 pregnant women are planned to be included in the study. Data will be collected with the
        'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety
        Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood
        Preparation Education" program will be applied to the experimental group for a period of four
        weeks (a month (each week, once a week in total four sessions)). Within the scope of the
        "Childbirth and Parenthood Preparation training" program; Physiological and psychological
        changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and
        substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support
        during pregnancy, pregnancy follow-ups, routine examinations and immunization, common
        problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and
        what to do, risky pregnancies, drug and human medicinal product management during pregnancy,
        labor process, drug-free methods for coping with labor pain, postpartum period and its
        characteristics, physiological changes in the mother after birth, psychological changes in
        puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the
        postpartum period, postpartum contraception methods will be explained. It is thought that the
        results of the research will contribute to the welfare of pregnant women by reducing maternal
        health needs, pregnancy-related anxiety and fetal health anxiety levels.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized-controlled trial with pretest-posttest control group
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Levels of Maternal Health Needs
  time frame: 1 months
  description: Maternal Health Needs is one of the primary outcomes. This will be measured using 'Maternal Health Needs Scale (MHNS) '. The minimum score that can be obtained from the scale is "23", the maximum score is "115", and as the scale score increases, maternal health needs also increase.
  measure: Pregnancy-Related Anxiety Levels
  time frame: 1 months
  description: Pregnancy related anxiety level is another outcomes. This will be mesured using "Pregnancy-Related Anxiety Scale- Revision 2". The minimum score that can be obtained from the scale is "11", the maximum score is "55", as the score obtained from the scale increases, the level of anxiety in pregnancy also increases.
  measure: Fetal Health Anxiety Levels
  time frame: 1 months
  description: Fetal Health Anxiety level is another outcomes. This will be mesured using "Fetal Health Anxiety Inventory (FHAI)". The minimum score that can be obtained from the scale is "0", the maximum score is "42", as the total score from the scale increases, the level of fetal health anxiety increases.
  arm group label: Experimental group
  arm group type: Experimental
  description: The Childbirth and Parenthood Preparation Education program
  arm group label: Control group
  arm group type: No Intervention
  description: No intervention
  intervention type: Behavioral
  intervention name: The Childbirth and Parenthood Preparation Education
  description: The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of 1 month (each week, once a week in total four sessions).
  arm group label: Experimental group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Pregnant women
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emine İbici Akça
  role: Principal Investigator
  affiliation: Amasya University
  last name: Emine İbici Akça, Ph.D
  phone: 03582115005-4723
  email: emine.akca@amasya.edu.tr
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Amasya University
  investigator full name: Emine Akca
  investigator title: Assist. Prof. Dr. in the Amasya University Midwifery Department
  mesh term: Anxiety Disorders
  sharing ipd: No