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/NCT06009887</url>
    </required_header>
    <id_info>
      <org_study_id>2020/1198</org_study_id>
      <nct_id>NCT06009887</nct_id>
    </id_info>
    <brief_title>Motivational Interview in Primiparous Pregnants With Low Belief in Normal Birth</brief_title>
    <official_title>The Effect of Motivational Interviews of Primiparous Pregnants With Low Belief in Normal Birth on Medical and Natural Birth Beliefs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inonu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inonu 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>
        This study aims to determine the effect of motivational interviews made with primiparous&#xD;
        pregnant women with low belief in normal birth on medical and natural birth belief. This&#xD;
        randomized controlled study was conducted in a randomized controlled manner with a total of&#xD;
        148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern&#xD;
        Turkey (74 trials, 74 controls). In the study, a total of four sessions of motivational&#xD;
        interviews were conducted with the primiparous pregnant women in the experimental group, one&#xD;
        week apart. No intervention was applied to the women in the control group. Research data&#xD;
        Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural&#xD;
        and medical birth belief) Scale (BBS) were used. Descriptive statistics, Pearson's chi-square&#xD;
        test, and dependent and independent t-test were used to analyze the data.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 15, 2021</start_date>
    <completion_date type="Actual">September 15, 2021</completion_date>
    <primary_completion_date type="Actual">February 20, 2021</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Belief Scale for Normal Delivery (BSND)</measure>
      <time_frame>up to 4 weeks</time_frame>
      <description>It was developed to evaluate the beliefs and tendencies of pregnant women towards normal birth. The scale is a five-point Likert type and is scored as I completely agree (5), agree (4), undecided (3), disagree (2), strongly disagree (1). A minimum of 24 and a maximum of 120 points can be obtained from the scale. If the total score from the scale is between 24 and 56, low, between 57 and 88, moderate, and between 89 and 120, high-level beliefs and tendency towards normal birth are in question. As the average score obtained from the scale increases, the beliefs and tendencies of pregnant women about normal birth increase.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Birth Beliefs (Natural and medical birth belief) Scale (BBS)</measure>
      <time_frame>Baseline and 4 weeks</time_frame>
      <description>While one of the sub-dimensions of the scale used to evaluate the basic belief levels of women about childbirth evaluates birth as a natural process, the other sub-dimension considers birth as a medical/medical process. The scale consists of 11 items in total, including 5 items (items 3, 5, 7, 8, and 11) for the belief in the natural process of birth and 6 items (items 1, 2, 4, 6, 9, and 10) for the belief in the medical/medical process. consists of. The scale score is obtained by dividing the total score of the items belonging to each sub-dimension by the number of items belonging to that sub-dimension. The group with a high numerical value in the arithmetic mean result constitutes the birth belief of the woman. In this Likert-type scale, each item is scored between 1 and 5 scales. The option &quot;strongly disagree&quot; receives 1 point, while the option &quot;strongly agree&quot; receives 5 points.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">148</enrollment>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>Experimental: İntervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Motivational interviewing is a counseling approach that pays special attention to the language of change, adopts a collaborative, goal-oriented communication style and aims to strengthen personal motivation and commitment to this change, revealing and discovering the reasons for the change in one's own, in an atmosphere of acceptance and empathy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Intervention: Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No interventions were made for those in the control group other than routine hospital practices.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational Interview</intervention_name>
      <description>Motivational interviewing is a collaborative speaking style to strengthen one's own motivation and commitment to change. Motivational interviewing is not a technique but a fundamental therapeutic style that does not try to make people change their behavior against their will. Proven to be effective in many areas of healthcare, motivational interviewing is widely used to help people resolve their indecision about change, explore their concerns, and set their own goals. The purpose of the motivational interviews conducted in the study is to increase the belief in normal and natural birth by enabling pregnant women to understand the factors that affect their low belief in normal birth, to take action for change and to believe in change, and to minimize the practices that cause medicalization of birth such as cesarean section by reducing medical birth beliefs.</description>
      <arm_group_label>Experimental: İntervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a low level of belief and tendency towards normal birth according to the Normal&#xD;
               Birth Belief Scale (between 24-56 points),&#xD;
  &#xD;
            -  Primiparous pregnant,&#xD;
  &#xD;
            -  According to the calculations made by USG of the pregnant women who do not know the&#xD;
               last menstruation date or the last menstruation date, 24-36 days of pregnancy. in the&#xD;
               week,&#xD;
  &#xD;
            -  Pregnant women who volunteered were included in the sample of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Premature birth,&#xD;
  &#xD;
            -  Having any risk diagnosed during pregnancy (such as preeclampsia, diabetes, heart&#xD;
               disease, placenta previa, oligohydramnios),&#xD;
  &#xD;
            -  Contraindications for normal vaginal delivery&#xD;
  &#xD;
            -  Developing cesarean indication,&#xD;
  &#xD;
            -  Not completing MG sessions,&#xD;
  &#xD;
            -  Pregnant women with deficiencies or errors in any of the forms in which the data were&#xD;
               obtained were excluded from the sample.&#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>
    <overall_official>
      <last_name>Çiğdem KARAKAYALI AY</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Midwifery, Faculty of Health Sciences, Sutcuimam University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Midwifery, Faculty of Health Sciences Sutcuimam University</name>
        <address>
          <city>Kahramanmaraş</city>
          <state>Onikişubat</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/27862837/</url>
      <description>The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial</description>
    </link>
    <results_reference>
      <citation>Rasouli M, AtashSokhan G, Keramat A, Khosravi A, Fooladi E, Mousavi SA. The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial. BJOG. 2017 Mar;124(4):631-639. doi: 10.1111/1471-0528.14397. Epub 2016 Nov 10.</citation>
      <PMID>27862837</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Inonu University</investigator_affiliation>
      <investigator_full_name>Çiğdem KARAKAYALI AY</investigator_full_name>
      <investigator_title>PhD Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Pregnancy</keyword>
    <keyword>Natural birth belief</keyword>
    <keyword>Medical birth belief</keyword>
    <keyword>Motivational interview.</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.</ipd_description>
    </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/NCT06009887
  org study id: 2020/1198
  nct id: NCT06009887
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to determine the effect of motivational interviews made with primiparous
        pregnant women with low belief in normal birth on medical and natural birth belief. This
        randomized controlled study was conducted in a randomized controlled manner with a total of
        148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern
        Turkey (74 trials, 74 controls). In the study, a total of four sessions of motivational
        interviews were conducted with the primiparous pregnant women in the experimental group, one
        week apart. No intervention was applied to the women in the control group. Research data
        Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural
        and medical birth belief) Scale (BBS) were used. Descriptive statistics, Pearson's chi-square
        test, and dependent and independent t-test were used to analyze the data.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Belief Scale for Normal Delivery (BSND)
  time frame: up to 4 weeks
  description: It was developed to evaluate the beliefs and tendencies of pregnant women towards normal birth. The scale is a five-point Likert type and is scored as I completely agree (5), agree (4), undecided (3), disagree (2), strongly disagree (1). A minimum of 24 and a maximum of 120 points can be obtained from the scale. If the total score from the scale is between 24 and 56, low, between 57 and 88, moderate, and between 89 and 120, high-level beliefs and tendency towards normal birth are in question. As the average score obtained from the scale increases, the beliefs and tendencies of pregnant women about normal birth increase.
  measure: Birth Beliefs (Natural and medical birth belief) Scale (BBS)
  time frame: Baseline and 4 weeks
  description: While one of the sub-dimensions of the scale used to evaluate the basic belief levels of women about childbirth evaluates birth as a natural process, the other sub-dimension considers birth as a medical/medical process. The scale consists of 11 items in total, including 5 items (items 3, 5, 7, 8, and 11) for the belief in the natural process of birth and 6 items (items 1, 2, 4, 6, 9, and 10) for the belief in the medical/medical process. consists of. The scale score is obtained by dividing the total score of the items belonging to each sub-dimension by the number of items belonging to that sub-dimension. The group with a high numerical value in the arithmetic mean result constitutes the birth belief of the woman. In this Likert-type scale, each item is scored between 1 and 5 scales. The option "strongly disagree" receives 1 point, while the option "strongly agree" receives 5 points.
  arm group label: Experimental: İntervention Group
  arm group type: Experimental
  description: Motivational interviewing is a counseling approach that pays special attention to the language of change, adopts a collaborative, goal-oriented communication style and aims to strengthen personal motivation and commitment to this change, revealing and discovering the reasons for the change in one's own, in an atmosphere of acceptance and empathy.
  arm group label: No Intervention: Control Group
  arm group type: No Intervention
  description: No interventions were made for those in the control group other than routine hospital practices.
  intervention type: Behavioral
  intervention name: Motivational Interview
  description: Motivational interviewing is a collaborative speaking style to strengthen one's own motivation and commitment to change. Motivational interviewing is not a technique but a fundamental therapeutic style that does not try to make people change their behavior against their will. Proven to be effective in many areas of healthcare, motivational interviewing is widely used to help people resolve their indecision about change, explore their concerns, and set their own goals. The purpose of the motivational interviews conducted in the study is to increase the belief in normal and natural birth by enabling pregnant women to understand the factors that affect their low belief in normal birth, to take action for change and to believe in change, and to minimize the practices that cause medicalization of birth such as cesarean section by reducing medical birth beliefs.
  arm group label: Experimental: İntervention Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Çiğdem KARAKAYALI AY
  role: Principal Investigator
  affiliation: Department of Midwifery, Faculty of Health Sciences, Sutcuimam University
  facility: 
  country: Turkey
  url: https://pubmed.ncbi.nlm.nih.gov/27862837/
  description: The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial
  citation: Rasouli M, AtashSokhan G, Keramat A, Khosravi A, Fooladi E, Mousavi SA. The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial. BJOG. 2017 Mar;124(4):631-639. doi: 10.1111/1471-0528.14397. Epub 2016 Nov 10.
  PMID: 27862837
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: Çiğdem KARAKAYALI AY
  investigator title: PhD Research Assistant
  sharing ipd: No
  ipd description: There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.