<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/NCT03834389</url>
  </required_header>
  <id_info>
    <org_study_id>RBurucu</org_study_id>
    <nct_id>NCT03834389</nct_id>
  </id_info>
  <brief_title>The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels</brief_title>
  <acronym>Case-Based</acronym>
  <official_title>The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels in Nursing Students: Mixed Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Selcuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Selcuk University</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>
      Second-year nursing students are randomly assigned to experimental and control groups. The&#xD;
      case-based teaching method was applied to the experimental group and the classical teaching&#xD;
      method was applied to the control group. After the initiative, both groups observed&#xD;
      differences in perceived competence and critical thinking levels. In addition, the focus&#xD;
      groups were interviewed with the experimental group and the opinions and suggestions about&#xD;
      the initiative were evaluated qualitatively and the total mix method was used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nursing secondary school students were randomized into two groups. Case-based training was&#xD;
      given to the experimental group, and classical training was given to the control group.&#xD;
      Critical thinking scale and self-efficacy scale both before and after the training were&#xD;
      applied to both groups. Posttest scores were calculated and compared for both groups. The&#xD;
      focus group consultation with 10 people from the experimental group was carried out and the&#xD;
      opinions and suggestions about the initiative were taken and evaluated. Permission was&#xD;
      obtained in writing from all institutions before and after the participants, and the study&#xD;
      was conducted by creating ethical conditions.Four separate training cases were given to the&#xD;
      experimental group. the control group continued the classical training and no intervention&#xD;
      was made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CRITICAL THINKING TENDENCY SCALE</measure>
    <time_frame>4 months</time_frame>
    <description>It was developed by a Turkish researcher and reliability of validity was done. The scale covers 49.161% of the variance. Factor loads range from 0.33 to 0.71. Sub-dimensions: metacity, flexibility, systematicness, determination and patience, open mindedness. The scale consists of 49 questions in total. Scale your scale; I totally agree (5), I mostly agree (4), Partially agree (3), I mostly do not agree (2), I never agree (1). The test retest correlation coefficient of the scale was 0.761 and the correlation coefficient between the two half scores was 0.95. The Cronbach Alpha coefficient is 0.963. Confirmatory factor analysis was performed with the AMOS program (Ratio = 2778.981, Sd = 1073, X2 / Sd = 2.590, GFI = 0.903, CFI = 0.932, RMSEA = 0.038). The total score ranges from 49 to 245, with a high score indicating a high tendency to think critically</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of case-based learning method on self-efficacy level</measure>
    <time_frame>4 months</time_frame>
    <description>The German version was originally used by Schwarzer. It was originally prepared as 20 items, then reduced to 10 items. Over time, it has been translated and used in more than twenty languages. Item total correlations are between 0.30 and 0.77. Reliability of Turkish validity was done; Alpha internal consistency coefficient was 0.79-0.63, total alpha coefficient was 0.83. Test-retest reliability coefficient of the scale is r = 0.80, p &lt;0.001. Factor analys's results of the Turkish version show that it accounts for 47% of the total variance. The item total score correlation coefficients are between 0.37 and 0.59. The items of the scale have scores ranging from 1 to 4, with a total score ranging from 10 to 40. High score is considered as high self-efficacy perception.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Focus group interview</measure>
    <time_frame>4 months</time_frame>
    <description>Group suggestions and comments (qualitative study)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group: case-based teaching method applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group: classical teaching method applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Case- based Learning</intervention_name>
    <description>critical thinking, self efficacy, focus group interview</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Become a nursing 2nd year student&#xD;
&#xD;
          -  Want to participate in the research&#xD;
&#xD;
          -  Not to be in the health profession&#xD;
&#xD;
          -  Having passed the course of internal medicine nursing&#xD;
&#xD;
          -  Being the first to see the surgical diseases nursing course&#xD;
&#xD;
          -  Be able to devote time for case discussions outside of class&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Being a foreign national (Unable to speak / understand Turkish effectively)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Selçuk Univercity</name>
      <address>
        <city>Konya</city>
        <state>Selçuklu/Konya</state>
        <zip>0506234752</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 30, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Selcuk University</investigator_affiliation>
    <investigator_full_name>Rukiye Burucu</investigator_full_name>
    <investigator_title>Doctorate student</investigator_title>
  </responsible_party>
  <keyword>case- based learning</keyword>
  <keyword>critical thinking</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>nursing education</keyword>
  <keyword>nursing</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>it is planned that the work will be shared after the writing is completed</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/NCT03834389
org study id: RBurucu
nct id: NCT03834389
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Second-year nursing students are randomly assigned to experimental and control groups. The
      case-based teaching method was applied to the experimental group and the classical teaching
      method was applied to the control group. After the initiative, both groups observed
      differences in perceived competence and critical thinking levels. In addition, the focus
      groups were interviewed with the experimental group and the opinions and suggestions about
      the initiative were evaluated qualitatively and the total mix method was used.
Nursing secondary school students were randomized into two groups. Case-based training was
      given to the experimental group, and classical training was given to the control group.
      Critical thinking scale and self-efficacy scale both before and after the training were
      applied to both groups. Posttest scores were calculated and compared for both groups. The
      focus group consultation with 10 people from the experimental group was carried out and the
      opinions and suggestions about the initiative were taken and evaluated. Permission was
      obtained in writing from all institutions before and after the participants, and the study
      was conducted by creating ethical conditions.Four separate training cases were given to the
      experimental group. the control group continued the classical training and no intervention
      was made.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: CRITICAL THINKING TENDENCY SCALE
time frame: 4 months
description: It was developed by a Turkish researcher and reliability of validity was done. The scale covers 49.161% of the variance. Factor loads range from 0.33 to 0.71. Sub-dimensions: metacity, flexibility, systematicness, determination and patience, open mindedness. The scale consists of 49 questions in total. Scale your scale; I totally agree (5), I mostly agree (4), Partially agree (3), I mostly do not agree (2), I never agree (1). The test retest correlation coefficient of the scale was 0.761 and the correlation coefficient between the two half scores was 0.95. The Cronbach Alpha coefficient is 0.963. Confirmatory factor analysis was performed with the AMOS program (Ratio = 2778.981, Sd = 1073, X2 / Sd = 2.590, GFI = 0.903, CFI = 0.932, RMSEA = 0.038). The total score ranges from 49 to 245, with a high score indicating a high tendency to think critically
measure: Effect of case-based learning method on self-efficacy level
time frame: 4 months
description: The German version was originally used by Schwarzer. It was originally prepared as 20 items, then reduced to 10 items. Over time, it has been translated and used in more than twenty languages. Item total correlations are between 0.30 and 0.77. Reliability of Turkish validity was done; Alpha internal consistency coefficient was 0.79-0.63, total alpha coefficient was 0.83. Test-retest reliability coefficient of the scale is r = 0.80, p <0.001. Factor analys's results of the Turkish version show that it accounts for 47% of the total variance. The item total score correlation coefficients are between 0.37 and 0.59. The items of the scale have scores ranging from 1 to 4, with a total score ranging from 10 to 40. High score is considered as high self-efficacy perception.
measure: Focus group interview
time frame: 4 months
description: Group suggestions and comments (qualitative study)
arm group label: Experimental Group
arm group type: Experimental
description: Experimental group: case-based teaching method applied
arm group label: Control Group
arm group type: No Intervention
description: Control group: classical teaching method applied
intervention type: Behavioral
intervention name: Case- based Learning
description: critical thinking, self efficacy, focus group interview
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Selcuk University
investigator full name: Rukiye Burucu
investigator title: Doctorate student
sharing ipd: Undecided
ipd description: it is planned that the work will be shared after the writing is completed