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/NCT05971927</url>
    </required_header>
    <id_info>
      <org_study_id>TOKAT02</org_study_id>
      <nct_id>NCT05971927</nct_id>
    </id_info>
    <brief_title>Simulation Teaching Method and Vaginal Examination in Midwifery Students</brief_title>
    <official_title>The Effect of Simulation Teaching Method on Vaginal Examination Practice Skills and Self-Confidence Development in Labor in Midwifery Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tokat Gaziosmanpasa University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tokat Gaziosmanpasa 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 was planned to evaluate the effect of simulation teaching method on the ability to&#xD;
        apply vaginal examination in labor and self-confidence in midwifery students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two skills, abdominal palpation and vaginal examination, are used to clinically monitor the&#xD;
        progress of labor. Vaginal examination is the most accepted method to measure the progress of&#xD;
        labor.Vaginal examination, which is routinely applied in the evaluation of labor progress, is&#xD;
        an important part of midwifery care. However, it is reported that the accuracy level of&#xD;
        vaginal examination for new students is low. This essential skill is a learned&#xD;
        tactile/tactile skill that requires consistency to properly manage women in labor. Therefore,&#xD;
        it cannot be learned through observation alone; In order to acquire this skill, students need&#xD;
        to perform a large number of vaginal examinations in women who have given birth. The&#xD;
        usual/classic training technique for teaching vaginal examination is that the midwifery&#xD;
        student performs a vaginal examination on the woman in labor under the supervision of an&#xD;
        experienced obstetrician, and then the experienced obstetrician repeats this examination to&#xD;
        determine the accuracy of the trainee student's assessment. Simulation-based learning&#xD;
        improves the understanding, retention and active use of knowledge and skills, reduces the&#xD;
        student's pre-application anxiety, and increases self-confidence. It is seen that simulation,&#xD;
        which has been widely used in medical education in recent years, is also used as a teaching&#xD;
        method in the development of practice skills of midwifery students.There are several studies&#xD;
        in the literature evaluating the effect of simulation training on students' vaginal&#xD;
        examination skills and self-confidence.In a study conducted to evaluate the benefits of&#xD;
        simulation training in teaching obstetric vaginal examination techniques to medical students,&#xD;
        it was found that the vaginal examination accuracy of students who received simulation&#xD;
        training was significantly higher than those who did not receive simulation training. In this&#xD;
        study, it was concluded that simulation training helped inexperienced students improve their&#xD;
        vaginal examination skills before performing such procedures on real patients, interns who&#xD;
        performed simulated examination showed significantly higher accuracy in vaginal examination&#xD;
        evaluations than the control group. However, according to the available data, no study has&#xD;
        been found that examines the effect of simulation training on vaginal examination skills in&#xD;
        midwifery students.&#xD;
  &#xD;
        This study was planned to evaluate the effect of simulation teaching method on the ability to&#xD;
        apply vaginal examination in labor and self-confidence in midwifery students.&#xD;
  &#xD;
        Type of Study: The study was planned as a randomized controlled trial.&#xD;
  &#xD;
        Place and Time of the Research: The research was carried out at Tokat Gaziosmanpaşa&#xD;
        University Faculty of Health Sciences, Tokat Gaziosmanpaşa University Health Research and&#xD;
        Application Hospital and Tokat Provincial Health Directorate Tokat State Hospital between&#xD;
        10.02.2020-17.05.2020.&#xD;
  &#xD;
        Population and Sample of the Research:&#xD;
  &#xD;
        The universe of the research consisted of 66 students who took the Normal Birth and&#xD;
        Postpartum Period and Risky Birth and Postpartum Period course for the first time in the&#xD;
        Department of Midwifery, Faculty of Health Sciences, Tokat Gaziosmanpaşa University.&#xD;
  &#xD;
        Students who agreed to participate in the study voluntarily were included in the study.&#xD;
  &#xD;
        66 midwifery students forming the research sample were ranked from high to low according to&#xD;
        their general academic grade point average. After the group with the highest grade point&#xD;
        average was determined randomly (by drawing lots), the students were assigned to the&#xD;
        experimental and control groups, respectively.&#xD;
  &#xD;
        Data Collection Tools&#xD;
  &#xD;
        The Effect of Simulation Teaching Method on Vaginal Examination Practice Skills and&#xD;
        Self-Confidence Development in Midwifery Students Questionnaire The questionnaire consists of&#xD;
        three parts.&#xD;
  &#xD;
        A. Socio-demographic characteristics of students&#xD;
  &#xD;
        In this section, midwifery students' age, marital status, graduated school, family structure,&#xD;
        place of residence, education level of the mother and father, perception of income, where the&#xD;
        family lives, the presence of health personnel in the family members, their position, if any,&#xD;
        their satisfaction with the midwifery department. There are a total of 18 questions about how&#xD;
        they evaluate the difference between the preference order of the midwifery profession, the&#xD;
        general academic grade point average, the level of finding sufficient theoretical knowledge&#xD;
        and skills in vaginal examination, previous vaginal examination practice and examination&#xD;
        findings, and the findings of an experienced obstetrician.&#xD;
  &#xD;
        B. Students' self-confidence ratings on performing the vaginal examination application steps&#xD;
        This is the section in which the students rank their self-confidence in performing the&#xD;
        vaginal examination application steps (22 items) prepared by the researchers by examining the&#xD;
        literature. It is scored as I do not trust myself at all-1, I do not trust myself-2, I have&#xD;
        little confidence in myself-3, I have confidence in myself-4, I am very confident in&#xD;
        myself-5.C. Vaginal examination evaluation results of the students in the clinic&#xD;
  &#xD;
        C. Vaginal examination evaluation results of the students in the clinic This is the section&#xD;
        where the evaluation results (cervical effacement, cervical dilatation, presence of amniotic&#xD;
        membrane, presenting fetus part and fetal descent) of the midwifery student and experienced&#xD;
        health professional (midwife, nurse and doctor) in vaginal examinations performed on women in&#xD;
        the clinic for both groups are recorded.&#xD;
  &#xD;
        Application of the Research:&#xD;
  &#xD;
        All students who took the Normal Birth and Postpartum Period and Risky Birth and Birth and&#xD;
        Postpartum Period courses were given a theoretical lecture on the steps of vaginal&#xD;
        examination in labor and the criteria to be evaluated in vaginal examination, and a video on&#xD;
        the subject was watched.&#xD;
  &#xD;
        After giving information about the study, informed consent was obtained from all students who&#xD;
        voluntarily agreed to participate in the study.&#xD;
  &#xD;
        The students were asked to fill in the questionnaires prepared by the researchers, examining&#xD;
        the socio-demographic characteristics and vaginal examination experiences of the students,&#xD;
        and to rate their self-confidence in performing the vaginal examination application steps.&#xD;
  &#xD;
        The experimental group students, which were determined as random, performed eight different&#xD;
        vaginal examination scenarios on the fetal monitoring and labor progress model set in terms&#xD;
        of cervical effacement, dilatation and the presence of the presenting part and amniotic sac.&#xD;
  &#xD;
        The control group did not receive any simulation training.&#xD;
  &#xD;
        The students in both groups were asked to rate their self-confidence in performing the steps&#xD;
        of performing the vaginal examination for the second time before performing the first vaginal&#xD;
        examination on the woman in the clinic.&#xD;
  &#xD;
        Vaginal examination results (cervical effacement, cervical dilatation, presence of amniotic&#xD;
        membrane, presenting fetus part, and fetal descent) of the midwifery student and experienced&#xD;
        health professional (midwife, nurse and doctor) were recorded in the vaginal examinations&#xD;
        performed on women in the clinic for both groups.&#xD;
  &#xD;
        In this study, the vaginal examination procedure normally used by midwifery students during&#xD;
        their professional practice in health institutions was used.&#xD;
  &#xD;
        An experienced health professional performed the vaginal examination in the woman in labor,&#xD;
        then the midwifery student repeated the vaginal examination on the same woman under the&#xD;
        supervision of an experienced health professional and the evaluation findings were compared.&#xD;
  &#xD;
        Informed consent was obtained from the women before the vaginal examination, infection&#xD;
        control measures were taken during the examinations (hand washing, wearing sterile gloves and&#xD;
        avoiding frequent vaginal examinations), and the privacy of the women was respected as much&#xD;
        as possible. The findings of experienced health professionals were accepted as the gold&#xD;
        standard in the study. Student findings consistent with the findings of the experienced&#xD;
        healthcare professional were evaluated as correct, and student findings that were not&#xD;
        compatible with or could not be evaluated with the findings of the experienced healthcare&#xD;
        professional were evaluated as incorrect.&#xD;
  &#xD;
        Evaluation of Research Data:&#xD;
  &#xD;
        Descriptive statistics were calculated to give information about the general characteristics&#xD;
        of the research groups. Qualitative data were expressed as percentages and compared using the&#xD;
        Chi-Square Test or the Fisher Exact Test. Quantitative data were expressed as mean±standard&#xD;
        deviation, and were compared using the Independent Two-Group T-Test. P&lt;0.05 was considered&#xD;
        statistically significant. Calculations were made with ready-made statistical software.&#xD;
  &#xD;
        Ethical Aspect of Research:&#xD;
  &#xD;
        Institutional permission from Tokat Gaziosmanpaşa University Faculty of Health Sciences,&#xD;
        Tokat Gaziosmanpaşa University Health Research and Application Hospital and Tokat Provincial&#xD;
        Health Directorate Tokat State Hospital and Tokat Gaziosmanpaşa University Clinical Research&#xD;
        Ethics Committee approval were obtained for the research. Informed consent was obtained from&#xD;
        all participants (midwifery students and women in labor) who would participate in the study.&#xD;
  &#xD;
        Parameters Students' self-confidence ratings in performing the vaginal examination&#xD;
        application steps&#xD;
  &#xD;
        -Vaginal examination evaluation parameters (cervical effacement, cervical dilatation,&#xD;
        presence of amniotic membrane, presenting fetus part and fetal descent)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 12, 2019</start_date>
    <completion_date type="Actual">March 13, 2020</completion_date>
    <primary_completion_date type="Actual">March 13, 2020</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>Health Services Research</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Students' self-confidence ratings in performing the vaginal examination application steps</measure>
      <time_frame>At the beginning of the study</time_frame>
      <description>I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of &quot;I am not at all confident&quot;, &quot;I am not confident&quot; and &quot;I have little confidence in myself&quot; were combined as &quot;low self-confidence&quot;, while the categories of &quot;I am confident&quot; and &quot;I am very confident&quot; were combined as &quot;high self-confidence&quot;.&#xD;
  Each step was evaluated separately.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Students' self-confidence ratings in performing the vaginal examination application steps</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of &quot;I am not at all confident&quot;, &quot;I am not confident&quot; and &quot;I have little confidence in myself&quot; were combined as &quot;low self-confidence&quot;, while the categories of &quot;I am confident&quot; and &quot;I am very confident&quot; were combined as &quot;high self-confidence&quot;.&#xD;
  Each step was evaluated separately.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cervical effacement</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>as a percentage (accurate and wrong)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cervical dilatation</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>in centimeters (accurate and wrong)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presenting fetal part</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>head, breech etc. (accurate and wrong)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of amniotic membrane</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>intact or ruptured (accurate and wrong)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fetal descent</measure>
      <time_frame>Within 1-6 months after the start of the study</time_frame>
      <description>-3,-2,-1,0,+1,+2,+3 (accurate and wrong)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">66</enrollment>
    <condition>Vaginal Examination</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Simulation education</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control groups</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group did not receive any simulation training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Simulation education</intervention_name>
      <description>Randomly assigned experimental group students performed eight different vaginal examination scenarios in the laboratory on the fetal monitoring and labor progress model set for cervical dilatation, cervical effacement, presenting fetal part, presence of amniotic membrane and fetal descent. The researchers repeated the vaginal examination scenario and informed the students about the evaluation results after each student had performed the vaginal examination scenario prepared by the researchers. This process continued until the experimental group students completed eight different vaginal examination scenarios.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Midwifery students enrolled in Normal Birth and Postpartum Term Course in the&#xD;
               2019-2020 academic year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Students who did not volunteer to participate in the study&#xD;
  &#xD;
            -  Students who did not perform vaginal examination on real women at the clinic&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Döndü BATKIN ERTÜRK</last_name>
      <role>Principal Investigator</role>
      <affiliation>Midwifery</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tokat Gaziosmanpasa University</name>
        <address>
          <city>Tokat</city>
          <zip>60250</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Muliira RS, Seshan V, Ramasubramaniam S. Improving vaginal examinations performed by midwives. Sultan Qaboos Univ Med J. 2013 Aug;13(3):442-9. Epub 2013 Jun 25.</citation>
      <PMID>23984031</PMID>
    </reference>
    <reference>
      <citation>Chahine, E. B., Rizk, S., Young, M., Moynihan, A., Arluck, J., &amp; Walker, P. (2018). Intern Bootcamp Cervical Dilation Simulation: Findings and Assessment [34M]. Obstetrics &amp; Gynecology, 131, 150S.</citation>
    </reference>
    <reference>
      <citation>Pratinidhi, A., Patange, R., Patil, S., Salunkhe, J., &amp; Samson, S. (2014). Testing of simulation training device for assessment of cervical dilatation among nursing student of Karad, India.</citation>
    </reference>
    <reference>
      <citation>https://www.internationalmidwives.org/assets/files/general-files/2019/10/icm-competencies-en-print-october-2019_final_18-oct-5db05248843e8.pdf erişim tarihi: 15.11.2019</citation>
    </reference>
    <reference>
      <citation>Arias T, Tran A, Breaud J, Fournier JP, Bongain A, Delotte J. A prospective study into the benefits of simulation training in teaching obstetric vaginal examination. Int J Gynaecol Obstet. 2016 Jun;133(3):380-4. doi: 10.1016/j.ijgo.2015.08.028. Epub 2016 Feb 23.</citation>
      <PMID>26971257</PMID>
    </reference>
    <reference>
      <citation>Cass GK, Crofts JF, Draycott TJ. The use of simulation to teach clinical skills in obstetrics. Semin Perinatol. 2011 Apr;35(2):68-73. doi: 10.1053/j.semperi.2011.01.005.</citation>
      <PMID>21440813</PMID>
    </reference>
    <reference>
      <citation>Bastable, S. B. (2017). Nurse as educator: Principles of teaching and learning for nursing practice. jones &amp; bartlett learning</citation>
    </reference>
    <reference>
      <citation>Aslan, M. Günay, O. Çetinkaya, F. Mazıcıoğlu, M., (2002). Tıp Eğiticileri İçin Eğitim Becerileri Rehberi. Erciyes Üniversitesi Tıp Fakültesi, Yayın No:70, 80-88, Kayseri.</citation>
    </reference>
    <reference>
      <citation>McEwen BS, Sapolsky RM. Stress and cognitive function. Curr Opin Neurobiol. 1995 Apr;5(2):205-16. doi: 10.1016/0959-4388(95)80028-x.</citation>
      <PMID>7620309</PMID>
    </reference>
    <reference>
      <citation>Driscoll, Mp., (2005). Pyschology of Learning for İnstruction, 3rd Ed. New York: Pearson.</citation>
    </reference>
    <reference>
      <citation>Tiffen, J. Graf, N. Corbridge, S., (2009). Effectiveness of a Low-Fidelity Simulation Experience in Building Confidence Among Advanced Practice Nursing Graduate Students. Clinical Simulation in Nursing, 5(3), 113-117</citation>
    </reference>
    <reference>
      <citation>Nitsche JF, Shumard KM, Fino NF, Denney JM, Quinn KH, Bailey JC, Jijon R, Huang C, Kesty K, Whitecar PW, Grandis AS, Brost BC. Effectiveness of Labor Cervical Examination Simulation in Medical Student Education. Obstet Gynecol. 2015 Oct;126 Suppl 4:13S-20S. doi: 10.1097/AOG.0000000000001027.</citation>
      <PMID>26375554</PMID>
    </reference>
    <reference>
      <citation>Roosevelt L, Diebel M, Zielinski RE. Achieving competency in vaginal examinations: The challenge of balancing student learning needs with best practice in maternity care. Midwifery. 2018 Jun;61:39-41. doi: 10.1016/j.midw.2018.02.016. Epub 2018 Feb 23.</citation>
      <PMID>29524775</PMID>
    </reference>
    <reference>
      <citation>Abbas, A., Shaltout, A., &amp; Fathalla, M. (2019). The Merit of Simulation in Teaching Medical Interns Vaginal Examination on Laboring Women. American Journal of Obstetrics And Gynecology, 220(1).</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
      <investigator_full_name>Döndü BATKIN ERTÜRK</investigator_full_name>
      <investigator_title>doctoral lecturer</investigator_title>
    </responsible_party>
    <keyword>Midwifery student</keyword>
    <keyword>Vaginal examination</keyword>
    <keyword>Confidence</keyword>
    <keyword>Skill</keyword>
    <keyword>Simulation</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/NCT05971927
  org study id: TOKAT02
  nct id: NCT05971927
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was planned to evaluate the effect of simulation teaching method on the ability to
        apply vaginal examination in labor and self-confidence in midwifery students.
  Two skills, abdominal palpation and vaginal examination, are used to clinically monitor the
        progress of labor. Vaginal examination is the most accepted method to measure the progress of
        labor.Vaginal examination, which is routinely applied in the evaluation of labor progress, is
        an important part of midwifery care. However, it is reported that the accuracy level of
        vaginal examination for new students is low. This essential skill is a learned
        tactile/tactile skill that requires consistency to properly manage women in labor. Therefore,
        it cannot be learned through observation alone; In order to acquire this skill, students need
        to perform a large number of vaginal examinations in women who have given birth. The
        usual/classic training technique for teaching vaginal examination is that the midwifery
        student performs a vaginal examination on the woman in labor under the supervision of an
        experienced obstetrician, and then the experienced obstetrician repeats this examination to
        determine the accuracy of the trainee student's assessment. Simulation-based learning
        improves the understanding, retention and active use of knowledge and skills, reduces the
        student's pre-application anxiety, and increases self-confidence. It is seen that simulation,
        which has been widely used in medical education in recent years, is also used as a teaching
        method in the development of practice skills of midwifery students.There are several studies
        in the literature evaluating the effect of simulation training on students' vaginal
        examination skills and self-confidence.In a study conducted to evaluate the benefits of
        simulation training in teaching obstetric vaginal examination techniques to medical students,
        it was found that the vaginal examination accuracy of students who received simulation
        training was significantly higher than those who did not receive simulation training. In this
        study, it was concluded that simulation training helped inexperienced students improve their
        vaginal examination skills before performing such procedures on real patients, interns who
        performed simulated examination showed significantly higher accuracy in vaginal examination
        evaluations than the control group. However, according to the available data, no study has
        been found that examines the effect of simulation training on vaginal examination skills in
        midwifery students.
  
        This study was planned to evaluate the effect of simulation teaching method on the ability to
        apply vaginal examination in labor and self-confidence in midwifery students.
  
        Type of Study: The study was planned as a randomized controlled trial.
  
        Place and Time of the Research: The research was carried out at Tokat Gaziosmanpaşa
        University Faculty of Health Sciences, Tokat Gaziosmanpaşa University Health Research and
        Application Hospital and Tokat Provincial Health Directorate Tokat State Hospital between
        10.02.2020-17.05.2020.
  
        Population and Sample of the Research:
  
        The universe of the research consisted of 66 students who took the Normal Birth and
        Postpartum Period and Risky Birth and Postpartum Period course for the first time in the
        Department of Midwifery, Faculty of Health Sciences, Tokat Gaziosmanpaşa University.
  
        Students who agreed to participate in the study voluntarily were included in the study.
  
        66 midwifery students forming the research sample were ranked from high to low according to
        their general academic grade point average. After the group with the highest grade point
        average was determined randomly (by drawing lots), the students were assigned to the
        experimental and control groups, respectively.
  
        Data Collection Tools
  
        The Effect of Simulation Teaching Method on Vaginal Examination Practice Skills and
        Self-Confidence Development in Midwifery Students Questionnaire The questionnaire consists of
        three parts.
  
        A. Socio-demographic characteristics of students
  
        In this section, midwifery students' age, marital status, graduated school, family structure,
        place of residence, education level of the mother and father, perception of income, where the
        family lives, the presence of health personnel in the family members, their position, if any,
        their satisfaction with the midwifery department. There are a total of 18 questions about how
        they evaluate the difference between the preference order of the midwifery profession, the
        general academic grade point average, the level of finding sufficient theoretical knowledge
        and skills in vaginal examination, previous vaginal examination practice and examination
        findings, and the findings of an experienced obstetrician.
  
        B. Students' self-confidence ratings on performing the vaginal examination application steps
        This is the section in which the students rank their self-confidence in performing the
        vaginal examination application steps (22 items) prepared by the researchers by examining the
        literature. It is scored as I do not trust myself at all-1, I do not trust myself-2, I have
        little confidence in myself-3, I have confidence in myself-4, I am very confident in
        myself-5.C. Vaginal examination evaluation results of the students in the clinic
  
        C. Vaginal examination evaluation results of the students in the clinic This is the section
        where the evaluation results (cervical effacement, cervical dilatation, presence of amniotic
        membrane, presenting fetus part and fetal descent) of the midwifery student and experienced
        health professional (midwife, nurse and doctor) in vaginal examinations performed on women in
        the clinic for both groups are recorded.
  
        Application of the Research:
  
        All students who took the Normal Birth and Postpartum Period and Risky Birth and Birth and
        Postpartum Period courses were given a theoretical lecture on the steps of vaginal
        examination in labor and the criteria to be evaluated in vaginal examination, and a video on
        the subject was watched.
  
        After giving information about the study, informed consent was obtained from all students who
        voluntarily agreed to participate in the study.
  
        The students were asked to fill in the questionnaires prepared by the researchers, examining
        the socio-demographic characteristics and vaginal examination experiences of the students,
        and to rate their self-confidence in performing the vaginal examination application steps.
  
        The experimental group students, which were determined as random, performed eight different
        vaginal examination scenarios on the fetal monitoring and labor progress model set in terms
        of cervical effacement, dilatation and the presence of the presenting part and amniotic sac.
  
        The control group did not receive any simulation training.
  
        The students in both groups were asked to rate their self-confidence in performing the steps
        of performing the vaginal examination for the second time before performing the first vaginal
        examination on the woman in the clinic.
  
        Vaginal examination results (cervical effacement, cervical dilatation, presence of amniotic
        membrane, presenting fetus part, and fetal descent) of the midwifery student and experienced
        health professional (midwife, nurse and doctor) were recorded in the vaginal examinations
        performed on women in the clinic for both groups.
  
        In this study, the vaginal examination procedure normally used by midwifery students during
        their professional practice in health institutions was used.
  
        An experienced health professional performed the vaginal examination in the woman in labor,
        then the midwifery student repeated the vaginal examination on the same woman under the
        supervision of an experienced health professional and the evaluation findings were compared.
  
        Informed consent was obtained from the women before the vaginal examination, infection
        control measures were taken during the examinations (hand washing, wearing sterile gloves and
        avoiding frequent vaginal examinations), and the privacy of the women was respected as much
        as possible. The findings of experienced health professionals were accepted as the gold
        standard in the study. Student findings consistent with the findings of the experienced
        healthcare professional were evaluated as correct, and student findings that were not
        compatible with or could not be evaluated with the findings of the experienced healthcare
        professional were evaluated as incorrect.
  
        Evaluation of Research Data:
  
        Descriptive statistics were calculated to give information about the general characteristics
        of the research groups. Qualitative data were expressed as percentages and compared using the
        Chi-Square Test or the Fisher Exact Test. Quantitative data were expressed as mean±standard
        deviation, and were compared using the Independent Two-Group T-Test. P<0.05 was considered
        statistically significant. Calculations were made with ready-made statistical software.
  
        Ethical Aspect of Research:
  
        Institutional permission from Tokat Gaziosmanpaşa University Faculty of Health Sciences,
        Tokat Gaziosmanpaşa University Health Research and Application Hospital and Tokat Provincial
        Health Directorate Tokat State Hospital and Tokat Gaziosmanpaşa University Clinical Research
        Ethics Committee approval were obtained for the research. Informed consent was obtained from
        all participants (midwifery students and women in labor) who would participate in the study.
  
        Parameters Students' self-confidence ratings in performing the vaginal examination
        application steps
  
        -Vaginal examination evaluation parameters (cervical effacement, cervical dilatation,
        presence of amniotic membrane, presenting fetus part and fetal descent)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Students' self-confidence ratings in performing the vaginal examination application steps
  time frame: At the beginning of the study
  description: I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of "I am not at all confident", "I am not confident" and "I have little confidence in myself" were combined as "low self-confidence", while the categories of "I am confident" and "I am very confident" were combined as "high self-confidence".
  Each step was evaluated separately.
  measure: Students' self-confidence ratings in performing the vaginal examination application steps
  time frame: Within 1-6 months after the start of the study
  description: I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of "I am not at all confident", "I am not confident" and "I have little confidence in myself" were combined as "low self-confidence", while the categories of "I am confident" and "I am very confident" were combined as "high self-confidence".
  Each step was evaluated separately.
  measure: Cervical effacement
  time frame: Within 1-6 months after the start of the study
  description: as a percentage (accurate and wrong)
  measure: Cervical dilatation
  time frame: Within 1-6 months after the start of the study
  description: in centimeters (accurate and wrong)
  measure: Presenting fetal part
  time frame: Within 1-6 months after the start of the study
  description: head, breech etc. (accurate and wrong)
  measure: Presence of amniotic membrane
  time frame: Within 1-6 months after the start of the study
  description: intact or ruptured (accurate and wrong)
  measure: Fetal descent
  time frame: Within 1-6 months after the start of the study
  description: -3,-2,-1,0,+1,+2,+3 (accurate and wrong)
  arm group label: Experimental group
  arm group type: Experimental
  description: Simulation education
  arm group label: Control groups
  arm group type: No Intervention
  description: The control group did not receive any simulation training.
  intervention type: Behavioral
  intervention name: Simulation education
  description: Randomly assigned experimental group students performed eight different vaginal examination scenarios in the laboratory on the fetal monitoring and labor progress model set for cervical dilatation, cervical effacement, presenting fetal part, presence of amniotic membrane and fetal descent. The researchers repeated the vaginal examination scenario and informed the students about the evaluation results after each student had performed the vaginal examination scenario prepared by the researchers. This process continued until the experimental group students completed eight different vaginal examination scenarios.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Döndü BATKIN ERTÜRK
  role: Principal Investigator
  affiliation: Midwifery
  facility: 
  country: Turkey
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  PMID: 23984031
  citation: Chahine, E. B., Rizk, S., Young, M., Moynihan, A., Arluck, J., & Walker, P. (2018). Intern Bootcamp Cervical Dilation Simulation: Findings and Assessment [34M]. Obstetrics & Gynecology, 131, 150S.
  citation: Pratinidhi, A., Patange, R., Patil, S., Salunkhe, J., & Samson, S. (2014). Testing of simulation training device for assessment of cervical dilatation among nursing student of Karad, India.
  citation: https://www.internationalmidwives.org/assets/files/general-files/2019/10/icm-competencies-en-print-october-2019_final_18-oct-5db05248843e8.pdf erişim tarihi: 15.11.2019
  citation: Arias T, Tran A, Breaud J, Fournier JP, Bongain A, Delotte J. A prospective study into the benefits of simulation training in teaching obstetric vaginal examination. Int J Gynaecol Obstet. 2016 Jun;133(3):380-4. doi: 10.1016/j.ijgo.2015.08.028. Epub 2016 Feb 23.
  PMID: 26971257
  citation: Cass GK, Crofts JF, Draycott TJ. The use of simulation to teach clinical skills in obstetrics. Semin Perinatol. 2011 Apr;35(2):68-73. doi: 10.1053/j.semperi.2011.01.005.
  PMID: 21440813
  citation: Bastable, S. B. (2017). Nurse as educator: Principles of teaching and learning for nursing practice. jones & bartlett learning
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  citation: Tiffen, J. Graf, N. Corbridge, S., (2009). Effectiveness of a Low-Fidelity Simulation Experience in Building Confidence Among Advanced Practice Nursing Graduate Students. Clinical Simulation in Nursing, 5(3), 113-117
  citation: Nitsche JF, Shumard KM, Fino NF, Denney JM, Quinn KH, Bailey JC, Jijon R, Huang C, Kesty K, Whitecar PW, Grandis AS, Brost BC. Effectiveness of Labor Cervical Examination Simulation in Medical Student Education. Obstet Gynecol. 2015 Oct;126 Suppl 4:13S-20S. doi: 10.1097/AOG.0000000000001027.
  PMID: 26375554
  citation: Roosevelt L, Diebel M, Zielinski RE. Achieving competency in vaginal examinations: The challenge of balancing student learning needs with best practice in maternity care. Midwifery. 2018 Jun;61:39-41. doi: 10.1016/j.midw.2018.02.016. Epub 2018 Feb 23.
  PMID: 29524775
  citation: Abbas, A., Shaltout, A., & Fathalla, M. (2019). The Merit of Simulation in Teaching Medical Interns Vaginal Examination on Laboring Women. American Journal of Obstetrics And Gynecology, 220(1).
  responsible party type: Principal Investigator
  investigator affiliation: Tokat Gaziosmanpasa University
  investigator full name: Döndü BATKIN ERTÜRK
  investigator title: doctoral lecturer
  sharing ipd: No