<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/NCT04487353</url>
  </required_header>
  <id_info>
    <org_study_id>2020/256</org_study_id>
    <nct_id>NCT04487353</nct_id>
  </id_info>
  <brief_title>Teaching the Mechanism of Birth by Virtual Reality</brief_title>
  <official_title>Development And Use Of Virtual Reality Application In Teaching Birth Mechanism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karabuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Saglik Bilimleri Universitesi</source>
  <oversight_info>
    <has_dmc>Yes</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>
      With the virtual birth application,&#xD;
&#xD;
        -  Learning the physiology and mechanism of birth,&#xD;
&#xD;
        -  To monitor the progress of birth and to understand deviations from normal,&#xD;
&#xD;
        -  Learning normal birth,&#xD;
&#xD;
        -  It will provide the opportunity to see all the emergencies that may be encountered at&#xD;
           birth and besides these, the information will be remembered for a long time.&#xD;
&#xD;
      In this way, the effectiveness of virtual birth in midwifery education will be evaluated.&#xD;
&#xD;
      Teaching the birth, which is one of the cornerstones of midwifery education and where the&#xD;
      students find the opportunity to practice clinically, with virtual reality application, will&#xD;
      minimize clinical application errors and will provide early diagnosis of adverse conditions&#xD;
      such as fetal presentation and placental anomalies that may occur at birth. It is an&#xD;
      up-to-date and important subject that will enable them to see the stages of birth in three&#xD;
      dimensions with the virtual delivery application without any obstacle in midwifery education,&#xD;
      the birth process, the birth mechanisms of the baby from the birth canal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, many studies have shown that technology assisted learning is a new learning&#xD;
      approach (1); In particular, learning environments involving virtual reality (VR) techniques&#xD;
      have become a powerful tool for educators and students (3, 4). Significant progress has been&#xD;
      made in various fields, enabling students to interact with the virtual world. These&#xD;
      technologies support many educational activities originally offered in web-based learning&#xD;
      environments. In midwifery education, the use of simulation has become an important training&#xD;
      method in the last decade (2). Simulation is a method that reflects a clinical situation as&#xD;
      close to reality as possible, making it easier to understand and manage when this situation&#xD;
      is actually encountered in clinical practice. Ensuring patient safety, efforts to increase&#xD;
      students' competence have enabled the use of simulation to become more widespread in the&#xD;
      training of health professionals (5). Using virtual reality in midwifery education will&#xD;
      enable students to use midwifery practices effectively before going to clinical practice.&#xD;
      Teaching the birth, which is one of the cornerstones of midwifery education and where the&#xD;
      students find the opportunity to practice clinically, with virtual reality application, will&#xD;
      minimize clinical application errors and will provide early diagnosis of adverse conditions&#xD;
      such as fetal presentation and placental anomalies that may occur at birth.&#xD;
&#xD;
      Type of the Study: The study is an experimental study planned as an experimental and control&#xD;
      group.&#xD;
&#xD;
      The research consists of 2 parts. In Part I, Virtual Reality Application will be Developed.&#xD;
      Virtual birth software will be prepared through service procurement. For this, algorithms&#xD;
      will be created by the researchers by writing in detail the physiology, stages, mechanism and&#xD;
      anatomy of the woman in detail.&#xD;
&#xD;
      II. The application of the research will be done in the department.&#xD;
&#xD;
      SECTION I: Development of Virtual Reality Application&#xD;
&#xD;
      In the 1st part of the research, virtual birth software will be prepared through service&#xD;
      procurement. For this, algorithms will be created by the researchers by writing in detail the&#xD;
      physiology, stages, mechanism and anatomy of the woman in detail. This algorithm will be&#xD;
      transferred to the glasses based on the images and drawings of the anatomy of the woman from&#xD;
      the birth atlases and the real images shared on the internet at the moment of birth. As&#xD;
      stated in the budget form, services will be procured for the development of the virtual birth&#xD;
      software.&#xD;
&#xD;
      With the virtual birth application,&#xD;
&#xD;
        -  To learn the physiology and mechanism of birth,&#xD;
&#xD;
        -  To monitor the progress of the birth and to understand deviations from the normal,&#xD;
&#xD;
        -  Learning normal birth,&#xD;
&#xD;
        -  It will provide the opportunity to see all the emergencies that may be encountered at&#xD;
           birth and besides these, the information will be remembered for a long time. In this&#xD;
           way, the effectiveness of virtual birth in midwifery education will be evaluated.&#xD;
&#xD;
      II. Department: Application of the Research&#xD;
&#xD;
      In this last part of the research, the application part of the research has been started. The&#xD;
      research will consist of 3 groups, 2 experimental groups and a control group. 35 students&#xD;
      will be admitted to each group as a result of G-power analysis calculated with 0.95 power.&#xD;
&#xD;
      The Universe of the research will consist of 464 Midwifery students studying at Karabük&#xD;
      University.&#xD;
&#xD;
      The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35&#xD;
      experiment II, as a result of the G-power analysis calculated by 0.95 power, among midwifery&#xD;
      students who took the birth mechanism 4 hours theoretically in their curriculum within the&#xD;
      scope of normal birth lesson.&#xD;
&#xD;
      At the first stage: after 4 hours of theory training for all three groups, the information&#xD;
      form (DEDBF) to be prepared by the researchers to be used in this research will be applied as&#xD;
      the first test.&#xD;
&#xD;
      In the second stage: No application will be made to the control group, computer-aided and&#xD;
      guided virtual reality application will be applied to the experimental group, and&#xD;
      computer-free and non-guided virtual application will be monitored to the experimental group&#xD;
      II.&#xD;
&#xD;
      In the third stage: DEDBF questions will be replaced and posttests will be applied. After the&#xD;
      4-hour theory training for the control group, the post-test will be done after the virtual&#xD;
      birth application is watched on the experiment groups. Also, at this stage, &quot;Cognitive Load&#xD;
      Scale&quot; and &quot;Feel of Inventory&quot; will be applied to the experimental groups after the&#xD;
      application.&#xD;
&#xD;
      In the fourth stage: After three weeks, the DEDBF will be applied again to the three groups,&#xD;
      and the effectiveness of the application of virtual birth will be examined in recalling and&#xD;
      recalling the information.&#xD;
&#xD;
      During applications, experiment and control group videos and images will be taken and&#xD;
      published visually in the thesis.&#xD;
&#xD;
      Students who could not participate in the study and were selected as a control group in&#xD;
      randomization will also be provided with virtual reality glasses after the study, so that all&#xD;
      students will see the virtual birth application and equality will be achieved.&#xD;
&#xD;
      Data Collection Tools:&#xD;
&#xD;
      Data collection form: It is planned to apply a form consisting of 15 questions, which&#xD;
      includes the characteristics of the participants such as age, marital status, educational&#xD;
      status and family type.&#xD;
&#xD;
      Birth Action Assessment Information Scale (DEDBF): The scale will be prepared by the&#xD;
      researchers themselves for use in this thesis. For the preparation of the form, the latest&#xD;
      literature information was reviewed by the researchers, the midwifery core curriculum (EUÇEP)&#xD;
      created by YÖK, and a 42-question information form containing items on the physiology, stages&#xD;
      and mechanism of delivery was prepared. The items in the information form will be presented&#xD;
      to the students in the form of a full sentence that can be true or false, and students will&#xD;
      be asked to answer these statements as &quot;True&quot; or &quot;False&quot;. Total response time is 30 minutes.&#xD;
      Correct answers will be evaluated as 1 point, Wrong answers will be evaluated as 0 points.&#xD;
      Wrong expressions were also used in the information form, and these items were coded in&#xD;
      reverse compared to others. The lowest score to be taken from the information form is 0 and&#xD;
      the highest total score is 42.&#xD;
&#xD;
      Cognitive Load Scale: Kılıç et al. (2004) &quot;Cognitive Load Scale&quot; (BYÖ) adapted to Turkish&#xD;
      will be used. It has single factor and nine points (very little, very little, little, partly&#xD;
      little, neither more nor less, more, more, more, more, more, more or more). The Cronbach&#xD;
      Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç&#xD;
      et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient&#xD;
      was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle&#xD;
      point is 5.00 and the highest point is 9.00. Participants scoring less than five points were&#xD;
      evaluated as &quot;cognitively overloaded&quot;, and participants scoring higher than five points were&#xD;
      evaluated as &quot;cognitively overloaded&quot;.&#xD;
&#xD;
      Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid&#xD;
      in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning&#xD;
      environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion /&#xD;
      Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface&#xD;
      Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor&#xD;
      analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the&#xD;
      5-factor structure was 41.197% and the reliability coefficient of the scale was .844.&#xD;
&#xD;
      Data Analysis of the Research: Analysis of the data of the study will be done using IBM SPSS&#xD;
      for Mac book 24 version.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2021</start_date>
  <completion_date type="Actual">February 12, 2022</completion_date>
  <primary_completion_date type="Actual">January 25, 2022</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>The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated from 0.95 power, among the midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Labor Evaluation Information Scale (LEIS)</measure>
    <time_frame>within 6 weeks</time_frame>
    <description>To measure the knowledge level of both groups about the mechanism of labor. To compare the changes in the knowledge level of students who have experienced VRT-LMA and students who have only theory education.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive Load Scale</measure>
    <time_frame>within 6 weeks</time_frame>
    <description>At this stage, &quot;Cognitive Load Scale&quot; will be applied to the experimental groups after the application.&#xD;
It has single factor and nine points (very little, very little, little, partially little, neither more nor less, more, more, more, more, more, more). The Cronbach Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle point is 5.00 and the highest point is 9.00. Participants who scored below five points were evaluated as &quot;cognitively overloaded&quot;, and participants who scored above five points were evaluated as &quot;cognitively overloaded&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Availability Sensitivity Scale</measure>
    <time_frame>within 6 weeks</time_frame>
    <description>At this stage, &quot;Availability Sensitivity Scale&quot; will be applied to the experimental groups after the application. Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the 5-factor structure was 41.197% and the reliability coefficient of the scale was .844. It is scored from 1 to 5. 1 ever, 5 are listed as completely.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Experiment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Labor Evaluation Information Scale (LEIS) was administered as a pre-test before applying to 30 students who had taken a course on childbirth. After the pre-test, the application was carried out with the &quot;Labor mechanism application developed with virtual reality technology (VRT-LMA)&quot;. Immediately after the application, data were collected with the &quot;LEIS&quot;, &quot;sense of presence scale&quot; and &quot;cognitive load scale&quot;. Post-test was performed again with the Labor Evaluation Information Scale (LEIS) 5 weeks after the application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Before the theory training, the Assessment Knowledge Scale (LEIS) was administered as a pre-test to 31 students in the control group who had taken a course on obstetrics. After the pre-test, theory training including birth knowledge was given. &quot;Labor mechanism application developed with virtual reality technology (VRT-LMA)&quot; was not applied to the control group. After 4 hours of theoretical training, the final test was performed using LEIS. After 5 weeks, the last test was repeated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labor mechanism application developed with virtual reality technology (VRT-LMA)</intervention_name>
    <description>In phase I: VRT-LMA application was developed. (Female in lithotomy position, bony pelvis, flexion of the coccyx back about 2 cm and the Hodge plane were modeled as lines. The theory training to be given to the control group was prepared in accordance with the curriculum.&#xD;
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.&#xD;
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.&#xD;
III. In the second stage: the post-test and analyzes were performed after 5 weeks in both groups.</description>
    <arm_group_label>Experiment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for the study; Being a 4th year student of Health Sciences University,&#xD;
        Gulhane Health Sciences Faculty, Midwifery Department, Volunteering to participate in&#xD;
        research Exclusion criteria from the study; Being a first year student. being a second year&#xD;
        student being a third year student&#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>
  <location>
    <facility>
      <name>University of Health Sciences Gülhane Faculty of Health Sciences</name>
      <address>
        <city>Ankara</city>
        <zip>06018</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://dergipark.org.tr/en/pub/kuey/issue/10357/126808</url>
    <description>Kılıç, A. G. E., &amp; Karadeniz, Ö. G. Ş. (2004). Hiper ortamlarda öğrencilerin bilişsel yüklenme ve kaybolma düzeylerinin belirlenmesi. Kuram ve Uygulamada Eğitim Yönetimi, 40(40), 562-579.</description>
  </link>
  <reference>
    <citation>Cooper S, Cant R, Porter J, Bogossian F, McKenna L, Brady S, Fox-Young S. Simulation based learning in midwifery education: a systematic review. Women Birth. 2012 Jun;25(2):64-78. doi: 10.1016/j.wombi.2011.03.004. Epub 2011 Apr 13.</citation>
    <PMID>21489894</PMID>
  </reference>
  <reference>
    <citation>Bjerrum AS, Hilberg O, van Gog T, Charles P, Eika B. Effects of modelling examples in complex procedural skills training: a randomised study. Med Educ. 2013 Sep;47(9):888-98. doi: 10.1111/medu.12199.</citation>
    <PMID>23931538</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 16, 2022</last_update_submitted>
  <last_update_submitted_qc>February 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>Sebahat Hüseyinoğlu</investigator_full_name>
    <investigator_title>Prelector (principal investigator)</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>I'm undecided now. I want to decide in the future</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04487353
org study id: 2020/256
nct id: NCT04487353
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
With the virtual birth application,

        -  Learning the physiology and mechanism of birth,

        -  To monitor the progress of birth and to understand deviations from normal,

        -  Learning normal birth,

        -  It will provide the opportunity to see all the emergencies that may be encountered at
           birth and besides these, the information will be remembered for a long time.

      In this way, the effectiveness of virtual birth in midwifery education will be evaluated.

      Teaching the birth, which is one of the cornerstones of midwifery education and where the
      students find the opportunity to practice clinically, with virtual reality application, will
      minimize clinical application errors and will provide early diagnosis of adverse conditions
      such as fetal presentation and placental anomalies that may occur at birth. It is an
      up-to-date and important subject that will enable them to see the stages of birth in three
      dimensions with the virtual delivery application without any obstacle in midwifery education,
      the birth process, the birth mechanisms of the baby from the birth canal.
In recent years, many studies have shown that technology assisted learning is a new learning
      approach (1); In particular, learning environments involving virtual reality (VR) techniques
      have become a powerful tool for educators and students (3, 4). Significant progress has been
      made in various fields, enabling students to interact with the virtual world. These
      technologies support many educational activities originally offered in web-based learning
      environments. In midwifery education, the use of simulation has become an important training
      method in the last decade (2). Simulation is a method that reflects a clinical situation as
      close to reality as possible, making it easier to understand and manage when this situation
      is actually encountered in clinical practice. Ensuring patient safety, efforts to increase
      students' competence have enabled the use of simulation to become more widespread in the
      training of health professionals (5). Using virtual reality in midwifery education will
      enable students to use midwifery practices effectively before going to clinical practice.
      Teaching the birth, which is one of the cornerstones of midwifery education and where the
      students find the opportunity to practice clinically, with virtual reality application, will
      minimize clinical application errors and will provide early diagnosis of adverse conditions
      such as fetal presentation and placental anomalies that may occur at birth.

      Type of the Study: The study is an experimental study planned as an experimental and control
      group.

      The research consists of 2 parts. In Part I, Virtual Reality Application will be Developed.
      Virtual birth software will be prepared through service procurement. For this, algorithms
      will be created by the researchers by writing in detail the physiology, stages, mechanism and
      anatomy of the woman in detail.

      II. The application of the research will be done in the department.

      SECTION I: Development of Virtual Reality Application

      In the 1st part of the research, virtual birth software will be prepared through service
      procurement. For this, algorithms will be created by the researchers by writing in detail the
      physiology, stages, mechanism and anatomy of the woman in detail. This algorithm will be
      transferred to the glasses based on the images and drawings of the anatomy of the woman from
      the birth atlases and the real images shared on the internet at the moment of birth. As
      stated in the budget form, services will be procured for the development of the virtual birth
      software.

      With the virtual birth application,

        -  To learn the physiology and mechanism of birth,

        -  To monitor the progress of the birth and to understand deviations from the normal,

        -  Learning normal birth,

        -  It will provide the opportunity to see all the emergencies that may be encountered at
           birth and besides these, the information will be remembered for a long time. In this
           way, the effectiveness of virtual birth in midwifery education will be evaluated.

      II. Department: Application of the Research

      In this last part of the research, the application part of the research has been started. The
      research will consist of 3 groups, 2 experimental groups and a control group. 35 students
      will be admitted to each group as a result of G-power analysis calculated with 0.95 power.

      The Universe of the research will consist of 464 Midwifery students studying at Karabük
      University.

      The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35
      experiment II, as a result of the G-power analysis calculated by 0.95 power, among midwifery
      students who took the birth mechanism 4 hours theoretically in their curriculum within the
      scope of normal birth lesson.

      At the first stage: after 4 hours of theory training for all three groups, the information
      form (DEDBF) to be prepared by the researchers to be used in this research will be applied as
      the first test.

      In the second stage: No application will be made to the control group, computer-aided and
      guided virtual reality application will be applied to the experimental group, and
      computer-free and non-guided virtual application will be monitored to the experimental group
      II.

      In the third stage: DEDBF questions will be replaced and posttests will be applied. After the
      4-hour theory training for the control group, the post-test will be done after the virtual
      birth application is watched on the experiment groups. Also, at this stage, "Cognitive Load
      Scale" and "Feel of Inventory" will be applied to the experimental groups after the
      application.

      In the fourth stage: After three weeks, the DEDBF will be applied again to the three groups,
      and the effectiveness of the application of virtual birth will be examined in recalling and
      recalling the information.

      During applications, experiment and control group videos and images will be taken and
      published visually in the thesis.

      Students who could not participate in the study and were selected as a control group in
      randomization will also be provided with virtual reality glasses after the study, so that all
      students will see the virtual birth application and equality will be achieved.

      Data Collection Tools:

      Data collection form: It is planned to apply a form consisting of 15 questions, which
      includes the characteristics of the participants such as age, marital status, educational
      status and family type.

      Birth Action Assessment Information Scale (DEDBF): The scale will be prepared by the
      researchers themselves for use in this thesis. For the preparation of the form, the latest
      literature information was reviewed by the researchers, the midwifery core curriculum (EUÇEP)
      created by YÖK, and a 42-question information form containing items on the physiology, stages
      and mechanism of delivery was prepared. The items in the information form will be presented
      to the students in the form of a full sentence that can be true or false, and students will
      be asked to answer these statements as "True" or "False". Total response time is 30 minutes.
      Correct answers will be evaluated as 1 point, Wrong answers will be evaluated as 0 points.
      Wrong expressions were also used in the information form, and these items were coded in
      reverse compared to others. The lowest score to be taken from the information form is 0 and
      the highest total score is 42.

      Cognitive Load Scale: Kılıç et al. (2004) "Cognitive Load Scale" (BYÖ) adapted to Turkish
      will be used. It has single factor and nine points (very little, very little, little, partly
      little, neither more nor less, more, more, more, more, more, more or more). The Cronbach
      Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç
      et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient
      was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle
      point is 5.00 and the highest point is 9.00. Participants scoring less than five points were
      evaluated as "cognitively overloaded", and participants scoring higher than five points were
      evaluated as "cognitively overloaded".

      Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid
      in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning
      environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion /
      Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface
      Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor
      analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the
      5-factor structure was 41.197% and the reliability coefficient of the scale was .844.

      Data Analysis of the Research: Analysis of the data of the study will be done using IBM SPSS
      for Mac book 24 version.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated from 0.95 power, among the midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
primary purpose: Basic Science
masking: Single (Investigator)
measure: Labor Evaluation Information Scale (LEIS)
time frame: within 6 weeks
description: To measure the knowledge level of both groups about the mechanism of labor. To compare the changes in the knowledge level of students who have experienced VRT-LMA and students who have only theory education.
measure: Cognitive Load Scale
time frame: within 6 weeks
description: At this stage, "Cognitive Load Scale" will be applied to the experimental groups after the application.
It has single factor and nine points (very little, very little, little, partially little, neither more nor less, more, more, more, more, more, more). The Cronbach Alpha internal consistency coefficient of the original version was found to be .90 (7). Kılıç et al. (2004) in the adaptation study, the Cronbach Alpha internal consistency coefficient was found as .78. The lowest point of the scores obtained from the scale is 1.00, the middle point is 5.00 and the highest point is 9.00. Participants who scored below five points were evaluated as "cognitively overloaded", and participants who scored above five points were evaluated as "cognitively overloaded".
measure: Availability Sensitivity Scale
time frame: within 6 weeks
description: At this stage, "Availability Sensitivity Scale" will be applied to the experimental groups after the application. Availability Sensitivity Scale: It is the scale whose original validity in Turkish was valid in 2018 by Gökoğlu et al. The scale is measured in virtual reality based learning environments. The scale has 5 factors (subscale), namely Participation (Factor 1), Cohesion / Surrounding (Factor 2), Sensory Commitment (Factor 3), Interaction (Factor 4) and Interface Quality (Factor 5) and consists of 29 questions (8 ). According to the exploratory factor analysis (AFA) and confirmatory factor analysis (CFA), the total variance explained by the 5-factor structure was 41.197% and the reliability coefficient of the scale was .844. It is scored from 1 to 5. 1 ever, 5 are listed as completely.
arm group label: Experiment Group
arm group type: Experimental
description: The Labor Evaluation Information Scale (LEIS) was administered as a pre-test before applying to 30 students who had taken a course on childbirth. After the pre-test, the application was carried out with the "Labor mechanism application developed with virtual reality technology (VRT-LMA)". Immediately after the application, data were collected with the "LEIS", "sense of presence scale" and "cognitive load scale". Post-test was performed again with the Labor Evaluation Information Scale (LEIS) 5 weeks after the application.
arm group label: Control Group
arm group type: No Intervention
description: Before the theory training, the Assessment Knowledge Scale (LEIS) was administered as a pre-test to 31 students in the control group who had taken a course on obstetrics. After the pre-test, theory training including birth knowledge was given. "Labor mechanism application developed with virtual reality technology (VRT-LMA)" was not applied to the control group. After 4 hours of theoretical training, the final test was performed using LEIS. After 5 weeks, the last test was repeated.
intervention type: Other
intervention name: Labor mechanism application developed with virtual reality technology (VRT-LMA)
description: In phase I: VRT-LMA application was developed. (Female in lithotomy position, bony pelvis, flexion of the coccyx back about 2 cm and the Hodge plane were modeled as lines. The theory training to be given to the control group was prepared in accordance with the curriculum.
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.
II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered.
III. In the second stage: the post-test and analyzes were performed after 5 weeks in both groups.
arm group label: Experiment Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
url: https://dergipark.org.tr/en/pub/kuey/issue/10357/126808
description: Kılıç, A. G. E., & Karadeniz, Ö. G. Ş. (2004). Hiper ortamlarda öğrencilerin bilişsel yüklenme ve kaybolma düzeylerinin belirlenmesi. Kuram ve Uygulamada Eğitim Yönetimi, 40(40), 562-579.
citation: Cooper S, Cant R, Porter J, Bogossian F, McKenna L, Brady S, Fox-Young S. Simulation based learning in midwifery education: a systematic review. Women Birth. 2012 Jun;25(2):64-78. doi: 10.1016/j.wombi.2011.03.004. Epub 2011 Apr 13.
PMID: 21489894
citation: Bjerrum AS, Hilberg O, van Gog T, Charles P, Eika B. Effects of modelling examples in complex procedural skills training: a randomised study. Med Educ. 2013 Sep;47(9):888-98. doi: 10.1111/medu.12199.
PMID: 23931538
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: Sebahat Hüseyinoğlu
investigator title: Prelector (principal investigator)
sharing ipd: No
ipd description: I'm undecided now. I want to decide in the future