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/NCT05967559</url>
    </required_header>
    <id_info>
      <org_study_id>DeRDEN</org_study_id>
      <nct_id>NCT05967559</nct_id>
    </id_info>
    <brief_title>Online Flipped Learning in Nursing Student</brief_title>
    <official_title>Effect Of The Online Flipped Learning Model on Students' Achievement, Critical Thinking Dispositions, and Self-Directed Learning Skills</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Namik Kemal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Namik Kemal 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>
        Cancer is one of the major health problems facing Turkey and the world. One of the methods&#xD;
        used to treat cancer is chemotherapy. During this treatment period, some side effects may&#xD;
        develop in patients. These developing symptoms can be managed with effective nursing&#xD;
        interventions, which in turn can increase the patient's quality of life. Managing these&#xD;
        symptoms is among the responsibilities of the nurse. The nurses' ability to effectively&#xD;
        manage the side effects of chemotherapy depends on gaining specific knowledge, attitudes, and&#xD;
        skills during their vocational training and the development of problem-solving and critical&#xD;
        thinking. The research was carried out to examine the effect of chemotherapy symptom&#xD;
        management education based on the online flipped learning model on the achievement, critical&#xD;
        thinking, and self-directed learning of nursing students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The online flipped learning method is an innovative learning approach that helps&#xD;
        develop critical thinking and self-directed learning skills and increases students' interest&#xD;
        in the course Aim: The research was carried out to examine the effect of chemotherapy symptom&#xD;
        management education based on the online flipped learning model on the achievement, critical&#xD;
        thinking, and self-directed learning of nursing students.&#xD;
  &#xD;
        Methods: This research is a randomized controlled trial. The sample consisted of 68 students&#xD;
        divided into experiment and control groups. The training program based on traditional&#xD;
        learning was applied to the control group, online flipped learning was applied to the&#xD;
        experiment group, and each group received training on chemotherapy symptom management for one&#xD;
        hour per week for six weeks. The researchers evaluated the results by applying the&#xD;
        Chemotherapy Symptom Management Knowledge Test (CSMKT), the Marmara Critical Thinking&#xD;
        Dispositions Scale (MCTDS), and the Self-Directed Learning Skills Scale (SDLSS) to the&#xD;
        control and experiment groups before, right after the training, and one month after the&#xD;
        training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 10, 2020</start_date>
    <completion_date type="Actual">July 1, 2022</completion_date>
    <primary_completion_date type="Actual">July 29, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The students who were informed about the research, and after obtaining their individual consent, the Chemotherapy Symptom Management Knowledge Test , the Marmara Critical Thinking Dispositions Scale , and the Self-Directed Learning Skills Scale were administered using an online questionnaire. Chemotherapy symptom management training was conducted online for six weeks, one hour per week, for experiment and control groups. The research began with the control group to minimize the interaction between the students in the experiment and control groups. Then the experiment group practices were carried out after the control group's program was completed.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The aim of the research was to reduce the bias by using a single-blind technique.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Chemotherapy Symptom Management Knowledge Test (CSMKT)</measure>
      <time_frame>1 month</time_frame>
      <description>The Chemotherapy Symptom Management Knowledge Test (CSMKT) was developed by the researchers to evaluate the impact of chemotherapy symptom management training based on the online flipped learning model. The measurement tool was presented to the expert opinion. Necessary corrections were made in accordance with the views of the experts and validity and reliability analyzes were carried. The test consists of 25 questions with a total of five options.The minimum score that can be attainable from the scale is 0, and the maximum score is 100. As the total score increases, the academic success of the student increases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Marmara Critical Thinking Dispositions Scale (MCTDS)</measure>
      <time_frame>1 month</time_frame>
      <description>The MCTDS was developed by Özgenel and Çetin (2018). The scale includes 28 items and six subdimensions: reasoning (six items), reaching judgment (six items), searching for evidence (four items), searching for the truth (four items), open-mindedness (four items), and systematicity (four items). It is a five-point Likert-type scale (5 = Always, 1 = Never). There are no reverse-scored items in the scale. The minimum score that can be attainable from the scale is 28, and the maximum score is 140. The Cronbach's alpha internal consistency coefficient of the scale was determined as α = 0.91 As the total score increases, the student's critical thinking dispositions increases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Directed Learning Skills Scale (SDLSS)</measure>
      <time_frame>1 month</time_frame>
      <description>The SDLLS was developed by Aşkın Tekkol and Demirel (2018). The scale includes 21 items and four subdimensions: motivation (seven items), self-control (five items), self-monitoring (five items), and self-confidence (four items). It is a five-point Likert-type scale (1 = Always, 5 = Never). There are no reverse-scored items in the scale. While the minimum score of the scale is 21, the maximum score is 105. The overall reliability, the Cronbach's alpha internal consistency coefficient, was determined as α = 0.89. As the total score increases, the student's self-directed learning skills increases.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">68</enrollment>
    <condition>Chemotherapy Effect</condition>
    <arm_group>
      <arm_group_label>Experiment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group received online flipped learning training for six weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control groups</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The control group received traditional learning training for 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Online Flipped Learning Group</intervention_name>
      <description>The experimental group is the group that receives online flipped learning training.</description>
      <arm_group_label>Experiment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional learning Group</intervention_name>
      <description>The control group is the group that received traditional learning training.</description>
      <arm_group_label>Control groups</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Second-year students who took the course basics of nursing, internal medicine nursing,&#xD;
               physiology, pathology, and computer courses and were able to actively use the computer&#xD;
               and voluntarily participated in the research were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Students in other classes&#xD;
  &#xD;
            -  Those who did not volunteer to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dilek Erden, PhD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Namik Kemal University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tekirdağ Namık Kemal University</name>
        <address>
          <city>Tekirdağ</city>
          <zip>59400</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Namik Kemal University</investigator_affiliation>
      <investigator_full_name>Dilek Erden</investigator_full_name>
      <investigator_title>Principal Investigator Dr.</investigator_title>
    </responsible_party>
    <keyword>academic achievement</keyword>
    <keyword>chemotherapy</keyword>
    <keyword>critical thinking</keyword>
    <keyword>online learning</keyword>
    <keyword>nursing students</keyword>
    <keyword>active learning</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/NCT05967559
  org study id: DeRDEN
  nct id: NCT05967559
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cancer is one of the major health problems facing Turkey and the world. One of the methods
        used to treat cancer is chemotherapy. During this treatment period, some side effects may
        develop in patients. These developing symptoms can be managed with effective nursing
        interventions, which in turn can increase the patient's quality of life. Managing these
        symptoms is among the responsibilities of the nurse. The nurses' ability to effectively
        manage the side effects of chemotherapy depends on gaining specific knowledge, attitudes, and
        skills during their vocational training and the development of problem-solving and critical
        thinking. The research was carried out to examine the effect of chemotherapy symptom
        management education based on the online flipped learning model on the achievement, critical
        thinking, and self-directed learning of nursing students.
  Background: The online flipped learning method is an innovative learning approach that helps
        develop critical thinking and self-directed learning skills and increases students' interest
        in the course Aim: The research was carried out to examine the effect of chemotherapy symptom
        management education based on the online flipped learning model on the achievement, critical
        thinking, and self-directed learning of nursing students.
  
        Methods: This research is a randomized controlled trial. The sample consisted of 68 students
        divided into experiment and control groups. The training program based on traditional
        learning was applied to the control group, online flipped learning was applied to the
        experiment group, and each group received training on chemotherapy symptom management for one
        hour per week for six weeks. The researchers evaluated the results by applying the
        Chemotherapy Symptom Management Knowledge Test (CSMKT), the Marmara Critical Thinking
        Dispositions Scale (MCTDS), and the Self-Directed Learning Skills Scale (SDLSS) to the
        control and experiment groups before, right after the training, and one month after the
        training.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: The students who were informed about the research, and after obtaining their individual consent, the Chemotherapy Symptom Management Knowledge Test , the Marmara Critical Thinking Dispositions Scale , and the Self-Directed Learning Skills Scale were administered using an online questionnaire. Chemotherapy symptom management training was conducted online for six weeks, one hour per week, for experiment and control groups. The research began with the control group to minimize the interaction between the students in the experiment and control groups. Then the experiment group practices were carried out after the control group's program was completed.
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: The aim of the research was to reduce the bias by using a single-blind technique.
  measure: Chemotherapy Symptom Management Knowledge Test (CSMKT)
  time frame: 1 month
  description: The Chemotherapy Symptom Management Knowledge Test (CSMKT) was developed by the researchers to evaluate the impact of chemotherapy symptom management training based on the online flipped learning model. The measurement tool was presented to the expert opinion. Necessary corrections were made in accordance with the views of the experts and validity and reliability analyzes were carried. The test consists of 25 questions with a total of five options.The minimum score that can be attainable from the scale is 0, and the maximum score is 100. As the total score increases, the academic success of the student increases.
  measure: Marmara Critical Thinking Dispositions Scale (MCTDS)
  time frame: 1 month
  description: The MCTDS was developed by Özgenel and Çetin (2018). The scale includes 28 items and six subdimensions: reasoning (six items), reaching judgment (six items), searching for evidence (four items), searching for the truth (four items), open-mindedness (four items), and systematicity (four items). It is a five-point Likert-type scale (5 = Always, 1 = Never). There are no reverse-scored items in the scale. The minimum score that can be attainable from the scale is 28, and the maximum score is 140. The Cronbach's alpha internal consistency coefficient of the scale was determined as α = 0.91 As the total score increases, the student's critical thinking dispositions increases.
  measure: Self-Directed Learning Skills Scale (SDLSS)
  time frame: 1 month
  description: The SDLLS was developed by Aşkın Tekkol and Demirel (2018). The scale includes 21 items and four subdimensions: motivation (seven items), self-control (five items), self-monitoring (five items), and self-confidence (four items). It is a five-point Likert-type scale (1 = Always, 5 = Never). There are no reverse-scored items in the scale. While the minimum score of the scale is 21, the maximum score is 105. The overall reliability, the Cronbach's alpha internal consistency coefficient, was determined as α = 0.89. As the total score increases, the student's self-directed learning skills increases.
  arm group label: Experiment group
  arm group type: Experimental
  description: The experimental group received online flipped learning training for six weeks.
  arm group label: Control groups
  arm group type: Other
  description: The control group received traditional learning training for 6 weeks.
  intervention type: Other
  intervention name: Online Flipped Learning Group
  description: The experimental group is the group that receives online flipped learning training.
  arm group label: Experiment group
  intervention type: Other
  intervention name: Traditional learning Group
  description: The control group is the group that received traditional learning training.
  arm group label: Control groups
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dilek Erden, PhD.
  role: Principal Investigator
  affiliation: Namik Kemal University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Namik Kemal University
  investigator full name: Dilek Erden
  investigator title: Principal Investigator Dr.
  sharing ipd: No