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/NCT05999409</url>
    </required_header>
    <id_info>
      <org_study_id>22-KAEK-166</org_study_id>
      <nct_id>NCT05999409</nct_id>
    </id_info>
    <brief_title>Normal Birth Management and Use of Simulation</brief_title>
    <official_title>Evaluation of the Effectiveness of Simulation Use in the Management of Normal Labor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ondokuz Mayıs University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tokat Gaziosmanpasa University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ondokuz Mayıs University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The research; It is planned to evaluate the effectiveness of the use of simulation in the&#xD;
        management of normal labor.&#xD;
  &#xD;
        The research was designed in a quasi-experimental randomized controlled type. The research is&#xD;
        carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023&#xD;
        academic year. The sample of the study consists of all third-year students who enrolled in&#xD;
        the Normal Birth and Postpartum Term course in the midwifery department for the first time&#xD;
        (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year.&#xD;
        These students are in the next 2022-2023 academic year. Registered for the Post Term Course).&#xD;
        In the literature; In experimental studies, it has been reported that a sample size of at&#xD;
        least 30 people is required in order to perform parametric tests (24). In this study, the&#xD;
        number of students in the groups was determined as 32, considering that they may have lost.&#xD;
        Students were divided into three groups as experimental (d1= High Reality simulator), (d2=&#xD;
        Medium Reality simulator) group and control group (d3= slide and video presentation). The&#xD;
        study is carried out with 96 students in total. The students who met the inclusion criteria&#xD;
        were given a sequence number and then randomly divided into 3 groups using the&#xD;
        https://www.randomizer.org online randomization program.&#xD;
  &#xD;
        Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth&#xD;
        Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning&#xD;
        (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introductory Information Form (IIF); It was created by the researchers by scanning the&#xD;
        literature (11,25-28). This form includes the socio-demographic characteristics of the&#xD;
        students, the presence of a health worker in the family, their normal birth practice status&#xD;
        and their simulation training (age, graduated high school, monthly income, presence of a&#xD;
        health worker in the family, normal birth practice monitoring and performance, simulation&#xD;
        training). receiving status etc.) consists of a total of 10 questions.&#xD;
  &#xD;
        Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the&#xD;
        literature (29-31). In the form, there are 50 items about the steps that the student should&#xD;
        do during the normal labor practice. Evaluation of the form is as &quot;he did&quot; and &quot;did not&quot; in&#xD;
        relation to the student's implementation of the activities to be observed during the normal&#xD;
        labor process steps. In the form, the student was given 2 points for each activity he did,&#xD;
        while 0 points were given for the activities he did not do. The lowest score that can be&#xD;
        obtained from the form is 0, and the highest score is 100. A high score will indicate high&#xD;
        skill, and a low score will indicate low skill.&#xD;
  &#xD;
        For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have&#xD;
        researched on learning techniques related to the management of normal labor were consulted.&#xD;
        The Lawshe technique was used to evaluate the content validity of the items in the form.&#xD;
        According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35).&#xD;
        No item with a content validity ratio below 0.99 was detected. In order to test the&#xD;
        intelligibility of the items, a pilot study was conducted with 10 students from another class&#xD;
        who had no knowledge of the content, and the form was given its final form.&#xD;
  &#xD;
        Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was&#xD;
        developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased&#xD;
        to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by&#xD;
        Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of&#xD;
        &quot;Satisfaction with Current Learning&quot; and &quot;Self-Confidence in Learning&quot;. The sub-title of&#xD;
        satisfaction with current learning consists of 5 items, the sub-title of self-confidence in&#xD;
        learning consists of 7 items and there is no negative item. The cronbach alpha value of the&#xD;
        scale for &quot;Satisfaction with Current Learning&quot; is .85, while it is .77 for &quot;Self-Confidence&#xD;
        in Learning&quot;, it is .89 for the total scale. Scale scores; It is obtained by dividing the sum&#xD;
        of the sub-dimensions by the number of items. As the total score obtained from the scale&#xD;
        increases, student satisfaction and self-confidence in learning also increase.&#xD;
  &#xD;
        Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by&#xD;
        Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz&#xD;
        van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5&#xD;
        sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from&#xD;
        1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All&#xD;
        statements in the scale are positive and there is no reverse coded item. Within the scope of&#xD;
        the scale, the basic competencies that midwives and nurses should have; care process, patient&#xD;
        safety, professional knowledge, communication and reflected behavior concepts are evaluated.&#xD;
        An increase in the score obtained from the sub-dimensions in the scale means that the&#xD;
        sub-dimension goal has been achieved for the student in the scenario (37).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 10, 2022</start_date>
    <completion_date type="Anticipated">October 10, 2023</completion_date>
    <primary_completion_date type="Actual">July 20, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>providing access to the number</measure>
      <time_frame>through study completion, an average of 9 month</time_frame>
      <description>enough practice by students</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Obstetric</condition>
    <arm_group>
      <arm_group_label>d1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>d2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>d3 (control)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>practice on birth simulator</intervention_name>
      <description>making attempts at labor</description>
      <arm_group_label>d1</arm_group_label>
      <arm_group_label>d2</arm_group_label>
      <other_name>d2=medium reality birth simulator</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The research includes all third-year students who registered for the first time to the&#xD;
               Normal Birth and Postpartum Term course in the midwifery department in the 2022-2023&#xD;
               academic year in the Department of Midwifery at the Faculty of Health Sciences.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having any of the above criteria&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>28 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Health Research and Training Hospital of Tokat Gaziosmanpaşa University</name>
        <address>
          <city>Tokat</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
      <investigator_full_name>Serap Ozturk Altinayak</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Data can be shared if requested from researchers.</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/NCT05999409
  org study id: 22-KAEK-166
  nct id: NCT05999409
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The research; It is planned to evaluate the effectiveness of the use of simulation in the
        management of normal labor.
  
        The research was designed in a quasi-experimental randomized controlled type. The research is
        carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023
        academic year. The sample of the study consists of all third-year students who enrolled in
        the Normal Birth and Postpartum Term course in the midwifery department for the first time
        (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year.
        These students are in the next 2022-2023 academic year. Registered for the Post Term Course).
        In the literature; In experimental studies, it has been reported that a sample size of at
        least 30 people is required in order to perform parametric tests (24). In this study, the
        number of students in the groups was determined as 32, considering that they may have lost.
        Students were divided into three groups as experimental (d1= High Reality simulator), (d2=
        Medium Reality simulator) group and control group (d3= slide and video presentation). The
        study is carried out with 96 students in total. The students who met the inclusion criteria
        were given a sequence number and then randomly divided into 3 groups using the
        https://www.randomizer.org online randomization program.
  
        Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth
        Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning
        (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.
  Introductory Information Form (IIF); It was created by the researchers by scanning the
        literature (11,25-28). This form includes the socio-demographic characteristics of the
        students, the presence of a health worker in the family, their normal birth practice status
        and their simulation training (age, graduated high school, monthly income, presence of a
        health worker in the family, normal birth practice monitoring and performance, simulation
        training). receiving status etc.) consists of a total of 10 questions.
  
        Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the
        literature (29-31). In the form, there are 50 items about the steps that the student should
        do during the normal labor practice. Evaluation of the form is as "he did" and "did not" in
        relation to the student's implementation of the activities to be observed during the normal
        labor process steps. In the form, the student was given 2 points for each activity he did,
        while 0 points were given for the activities he did not do. The lowest score that can be
        obtained from the form is 0, and the highest score is 100. A high score will indicate high
        skill, and a low score will indicate low skill.
  
        For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have
        researched on learning techniques related to the management of normal labor were consulted.
        The Lawshe technique was used to evaluate the content validity of the items in the form.
        According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35).
        No item with a content validity ratio below 0.99 was detected. In order to test the
        intelligibility of the items, a pilot study was conducted with 10 students from another class
        who had no knowledge of the content, and the form was given its final form.
  
        Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was
        developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased
        to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by
        Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of
        "Satisfaction with Current Learning" and "Self-Confidence in Learning". The sub-title of
        satisfaction with current learning consists of 5 items, the sub-title of self-confidence in
        learning consists of 7 items and there is no negative item. The cronbach alpha value of the
        scale for "Satisfaction with Current Learning" is .85, while it is .77 for "Self-Confidence
        in Learning", it is .89 for the total scale. Scale scores; It is obtained by dividing the sum
        of the sub-dimensions by the number of items. As the total score obtained from the scale
        increases, student satisfaction and self-confidence in learning also increase.
  
        Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by
        Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz
        van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5
        sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from
        1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All
        statements in the scale are positive and there is no reverse coded item. Within the scope of
        the scale, the basic competencies that midwives and nurses should have; care process, patient
        safety, professional knowledge, communication and reflected behavior concepts are evaluated.
        An increase in the score obtained from the sub-dimensions in the scale means that the
        sub-dimension goal has been achieved for the student in the scenario (37).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: providing access to the number
  time frame: through study completion, an average of 9 month
  description: enough practice by students
  arm group label: d1
  arm group type: Experimental
  description: NBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.
  arm group label: d2
  arm group type: Experimental
  description: An initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.
  arm group label: d3 (control)
  arm group type: No Intervention
  description: Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment.
  intervention type: Other
  intervention name: practice on birth simulator
  description: making attempts at labor
  arm group label: d1
  arm group label: d2
  other name: d2=medium reality birth simulator
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 28 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ondokuz Mayıs University
  investigator full name: Serap Ozturk Altinayak
  investigator title: assistant professor
  sharing ipd: Undecided
  ipd description: Data can be shared if requested from researchers.