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/NCT06004778</url>
    </required_header>
    <id_info>
      <org_study_id>Demet Sokun Ayaz</org_study_id>
      <nct_id>NCT06004778</nct_id>
    </id_info>
    <brief_title>The Effect of Motivational Support Program Applied to Adolescents on Sleep Quality and Academic Achievement</brief_title>
    <official_title>Lecturer (Academician at University)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        It was planned as a randomized controlled experimental study with a single-blind technique,&#xD;
        pretest-posttest control group and repetitive measurements, in order to determine the effect&#xD;
        of motivational support program applied to adolescents and education on sleep quality.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">January 19, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 19, 2024</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sleep quality Score</measure>
      <time_frame>up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)</time_frame>
      <description>Adolescents receiving motivational support programs have higher average sleep quality scores.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Academic Achievement Score</measure>
      <time_frame>up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)</time_frame>
      <description>Adolescents receiving motivational support program had higher academic achievement averages.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>High School 11th Grade Students</condition>
    <condition>Absence of Any Language, Hearing, Mental or Psychological Disability</condition>
    <condition>Turkish Speaking and Understanding</condition>
    <condition>Having a PUKI Index Above 5ı</condition>
    <condition>Absence of Any Chronic Disease</condition>
    <condition>Obtaining Permission From Parents and Students</condition>
    <arm_group>
      <arm_group_label>Motivational Support Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Training booklet will be provided.A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.Individual motivational interviews will be held with students and reminder messages will be sent twice a week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>educational support</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Training booklet will be provided. A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational Support Program</intervention_name>
      <description>In studies conducted on adolescents with poor sleep quality, no study using motivational interviewing technique was found.</description>
      <arm_group_label>Motivational Support Program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational support</intervention_name>
      <description>educational support</description>
      <arm_group_label>educational support</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  No language disorders&#xD;
  &#xD;
            -  No hearing disorders&#xD;
  &#xD;
            -  No mental disorders&#xD;
  &#xD;
            -  Bad sleep quality&#xD;
  &#xD;
            -  No chronic disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Sleeping pill&#xD;
  &#xD;
            -  Psychiatric illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Demet Sökün Ayaz</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Demet Sokun Ayaz</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004778
  org study id: Demet Sokun Ayaz
  nct id: NCT06004778
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  It was planned as a randomized controlled experimental study with a single-blind technique,
        pretest-posttest control group and repetitive measurements, in order to determine the effect
        of motivational support program applied to adolescents and education on sleep quality.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Sleep quality Score
  time frame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
  description: Adolescents receiving motivational support programs have higher average sleep quality scores.
  measure: Academic Achievement Score
  time frame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
  description: Adolescents receiving motivational support program had higher academic achievement averages.
  arm group label: Motivational Support Program
  arm group type: Experimental
  description: Training booklet will be provided.A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.Individual motivational interviews will be held with students and reminder messages will be sent twice a week.
  arm group label: educational support
  arm group type: Active Comparator
  description: Training booklet will be provided. A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.
  intervention type: Behavioral
  intervention name: Motivational Support Program
  description: In studies conducted on adolescents with poor sleep quality, no study using motivational interviewing technique was found.
  arm group label: Motivational Support Program
  intervention type: Behavioral
  intervention name: Educational support
  description: educational support
  arm group label: educational support
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Demet Sokun Ayaz
  investigator title: lecturer
  mesh term: Chronic Disease