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/NCT05994911</url>
    </required_header>
    <id_info>
      <org_study_id>Mindfulness</org_study_id>
      <nct_id>NCT05994911</nct_id>
    </id_info>
    <brief_title>Mindfulness Education in Adolescents</brief_title>
    <official_title>The Effect of Mindfulness Education on Interpersonal Style and Perceived Social Competence in Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ejdane Coskun</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Osmaniye Korkut Ata 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>
        Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and&#xD;
        perceived social competence in adolescents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the research, high school students will form the universe according to the education in&#xD;
        the relevant institution. Based on a study with a similar design, it was decided to include&#xD;
        60 people, 30 in the intervention group and 30 in the control group, according to the effect&#xD;
        size.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">November 13, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 13, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mindfulness training affects interpersonal style in adolescents.</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>It was developed to determine what style they use in interpersonal relationships. It is a self-assessment scale consisting of sixty items. The items are answered according to the question &quot;How much does it describe you&quot; and are answered in a 5-point Likert type as 0%, 25%, 50%, 75% and 100%. 0.1%, 1 point; 25%, 2 points; 50%, 3 points; 75% are evaluated with 4 points and 100% with 5 points. Accordingly, a minimum of 60 and a maximum of 300 points can be obtained.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mindfulness training affects perceived social competence in adolescents</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>The Perceived Social Competence Scale is a one-dimensional scale consisting of 6 items and items. The highest score that can be obtained from the scale is 30, and the lowest score is 6. It can be said that as the scores obtained from the Perceived Social Competence Scale, which does not have any reversed items, increase, the perceived social competency level of the individual also increases</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Mindfulness</condition>
    <arm_group>
      <arm_group_label>Mindfulness Training adolescent</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An 8-week interview will be conducted with the individuals in the experimental group in the research in which the mindfulness training psychiatric nursing approach is applied. The control group will continue their routine school life. Individuals in the experimental group will be trained as a group and initiatives will be implemented in line with the goals of the individuals and the objectives of the research.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Individuals in the control group will continue their school life.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Training</intervention_name>
      <description>The application is planned as 8 sessions and one session per week. Each session corresponds to one lesson hour and is approximately 30-40 minutes. In the content of the application, the individual's attention, mind, attitude, intention, thought; It has basic concepts such as the separation and merging process of thoughts in our minds, the deep processes of awareness, staying in the moment, values, focusing process, self-compassion, integration of awareness with other situations in life, meditation practices developed with practice, and the content summarized around these concepts. It is a program that tries to enable individuals to focus on the moment they live in, within the framework of these basic concepts. The program is divided into session titles such as &quot;Introduction to Mindfulness&quot;, &quot;Mind Awareness&quot;, &quot;Body Awareness&quot;, &quot;Emotion and Behavior Awareness&quot;, &quot;Self Compassion&quot;, &quot;Stress Awareness&quot;, &quot;Eating Awareness&quot;.</description>
      <arm_group_label>Mindfulness Training adolescent</arm_group_label>
      <other_name>Mindfulness</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          be a high school student&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Having any psychiatric illness that prevents adequate communication will not be included in&#xD;
          the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ejdane Coşkun, Lect.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ayşe İNEL MANAV, Assoc. Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hüsne Demirel, Assoc. Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University Ankara, Center, Türkiye, 06500</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yunus Ömer Arık, Grad. stud.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Korkut Ata University Osmaniye, Center, Türkiye, 80000</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ejdane Coşkun, Lect.</last_name>
      <phone>+905055498034</phone>
      <email>ejdane_1987@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayşe İNEL MANAV, Assoc. Prof</last_name>
      <email>ayseinel@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Türkiye</name>
        <address>
          <city>Osmaniye</city>
          <state>Korkut Ata University</state>
          <zip>80000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Osmaniye Korkut Ata University</investigator_affiliation>
      <investigator_full_name>Ejdane Coskun</investigator_full_name>
      <investigator_title>PhD, Lecturer</investigator_title>
    </responsible_party>
    <keyword>Mindfulness Training</keyword>
    <keyword>Adolescent</keyword>
    <keyword>Interpersonal Style</keyword>
    <keyword>Perceived Social Competence</keyword>
    <keyword>Psychiatric nursing</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/NCT05994911
  org study id: Mindfulness
  nct id: NCT05994911
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and
        perceived social competence in adolescents.
  In the research, high school students will form the universe according to the education in
        the relevant institution. Based on a study with a similar design, it was decided to include
        60 people, 30 in the intervention group and 30 in the control group, according to the effect
        size.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Mindfulness training affects interpersonal style in adolescents.
  time frame: up to 8 weeks
  description: It was developed to determine what style they use in interpersonal relationships. It is a self-assessment scale consisting of sixty items. The items are answered according to the question "How much does it describe you" and are answered in a 5-point Likert type as 0%, 25%, 50%, 75% and 100%. 0.1%, 1 point; 25%, 2 points; 50%, 3 points; 75% are evaluated with 4 points and 100% with 5 points. Accordingly, a minimum of 60 and a maximum of 300 points can be obtained.
  measure: Mindfulness training affects perceived social competence in adolescents
  time frame: up to 8 weeks
  description: The Perceived Social Competence Scale is a one-dimensional scale consisting of 6 items and items. The highest score that can be obtained from the scale is 30, and the lowest score is 6. It can be said that as the scores obtained from the Perceived Social Competence Scale, which does not have any reversed items, increase, the perceived social competency level of the individual also increases
  arm group label: Mindfulness Training adolescent
  arm group type: Experimental
  description: An 8-week interview will be conducted with the individuals in the experimental group in the research in which the mindfulness training psychiatric nursing approach is applied. The control group will continue their routine school life. Individuals in the experimental group will be trained as a group and initiatives will be implemented in line with the goals of the individuals and the objectives of the research.
  arm group label: Mindfulness
  arm group type: No Intervention
  description: Individuals in the control group will continue their school life.
  intervention type: Behavioral
  intervention name: Mindfulness Training
  description: The application is planned as 8 sessions and one session per week. Each session corresponds to one lesson hour and is approximately 30-40 minutes. In the content of the application, the individual's attention, mind, attitude, intention, thought; It has basic concepts such as the separation and merging process of thoughts in our minds, the deep processes of awareness, staying in the moment, values, focusing process, self-compassion, integration of awareness with other situations in life, meditation practices developed with practice, and the content summarized around these concepts. It is a program that tries to enable individuals to focus on the moment they live in, within the framework of these basic concepts. The program is divided into session titles such as "Introduction to Mindfulness", "Mind Awareness", "Body Awareness", "Emotion and Behavior Awareness", "Self Compassion", "Stress Awareness", "Eating Awareness".
  arm group label: Mindfulness Training adolescent
  other name: Mindfulness
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ejdane Coşkun, Lect.
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  last name: Ayşe İNEL MANAV, Assoc. Prof
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  last name: Hüsne Demirel, Assoc. Prof
  role: Principal Investigator
  affiliation: Gazi University Ankara, Center, Türkiye, 06500
  last name: Yunus Ömer Arık, Grad. stud.
  role: Principal Investigator
  affiliation: Korkut Ata University Osmaniye, Center, Türkiye, 80000
  last name: Ejdane Coşkun, Lect.
  phone: +905055498034
  email: ejdane_1987@hotmail.com
  last name: Ayşe İNEL MANAV, Assoc. Prof
  email: ayseinel@gmail.com
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Osmaniye Korkut Ata University
  investigator full name: Ejdane Coskun
  investigator title: PhD, Lecturer
  sharing ipd: No