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/NCT06012188</url>
    </required_header>
    <id_info>
      <org_study_id>Kilis7AralikU_E_S_KOÇ00</org_study_id>
      <nct_id>NCT06012188</nct_id>
    </id_info>
    <brief_title>Aged 3-6 on Children's Sleeping Habits</brief_title>
    <acronym>[Sleep]</acronym>
    <official_title>The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kilis 7 Aralik University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kilis 7 Aralik 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>
        One of the most important points in sleep health is the sleep habits of children. Natural&#xD;
        disasters cause sleep problems in children, increase or decrease in sleep duration, change in&#xD;
        sleep habits and adversely affect sleep quality. According to Erikson's theory of&#xD;
        psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children&#xD;
        begin to learn and apply the rules, and independence efforts are developed in the child.&#xD;
        Negative sleep behaviors and sleep problems are common during this period, but children can&#xD;
        develop positive sleep habits if properly and consistently guided by their parents. Rituals&#xD;
        such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and&#xD;
        gain sleep habits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research design is a randomized controlled experimental type study designed to evaluate&#xD;
        the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on&#xD;
        children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep&#xD;
        habits of children in the earthquake area by pre-interviewing the parents of children aged&#xD;
        3-6. Children aged 3-6 with sleep problems will be divided into control and experimental&#xD;
        groups according to their scale scores. The part up to this section constitutes the&#xD;
        preliminary test of our research.&#xD;
  &#xD;
        Children aged 3-6 years in the control group and their parents will not receive any&#xD;
        intervention.&#xD;
  &#xD;
        Families of the children in the experimental group will be given a sleep companion gift to&#xD;
        give to their children. Children's sleep habits scale will be applied as a post-test to&#xD;
        determine children's sleep problems 15 days after they receive a gift from their sleep&#xD;
        friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made&#xD;
        between pretest and posttest mean scores.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Children's Sleep Habits Scale</measure>
      <time_frame>15 day</time_frame>
      <description>The Children's Sleep Habits Scale will be used to determine children's sleep habits and sleep-related problems. Children's Sleep Habits Scale consists of 8 sub-dimensions and a total of 33 items.In grading the scale, parents are asked to respond as 1=rarely (0-1 times a week), 2=sometimes (2-4 times a week), and 3=usually (5-7 times a week). A minimum of 33 points and a maximum of 99 points are taken from the scale. The total test score is obtained by summing the scores obtained from the items one by one.&#xD;
  It is accepted that those who have a total score of 41 and above with CIAS have clinical sleep problems.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep Habits</condition>
    <condition>Child</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Children in the experimental group will be given a sleeping companion toy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be made on the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sleep toy</intervention_name>
      <description>The parents of the children in the experimental group will be given a sleeping companion toy to present to their children. At the end of 15 days, the Children's Sleep Habits scale will be applied as a post-test to evaluate the effect of the sleep companion toy.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages ranging from 3 to 6&#xD;
  &#xD;
            -  Earthquake living&#xD;
  &#xD;
            -  Parents being literate&#xD;
  &#xD;
            -  Parents and children who accepted the study and gave voluntary consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being a 3-6 year old child who has previously had a sleep disorder finding&#xD;
  &#xD;
            -  Being visually, hearing or speech impaired&#xD;
  &#xD;
            -  Children aged 3-6 with mental disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>FATMA KURUDİREK</last_name>
      <role>Principal Investigator</role>
      <affiliation>fsaban@atauni.edu.tr</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Türkan KADİROĞLU</last_name>
      <role>Principal Investigator</role>
      <affiliation>t.kadiroglu@atauni.edu.tr</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elif Simay KOÇ</last_name>
      <phone>05071499746</phone>
      <email>elifsimay.koc@kilis.edu.tr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kilis 7 Aralik University</investigator_affiliation>
      <investigator_full_name>Elif Simay KOÇ</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <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/NCT06012188
  org study id: Kilis7AralikU_E_S_KOÇ00
  nct id: NCT06012188
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  One of the most important points in sleep health is the sleep habits of children. Natural
        disasters cause sleep problems in children, increase or decrease in sleep duration, change in
        sleep habits and adversely affect sleep quality. According to Erikson's theory of
        psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children
        begin to learn and apply the rules, and independence efforts are developed in the child.
        Negative sleep behaviors and sleep problems are common during this period, but children can
        develop positive sleep habits if properly and consistently guided by their parents. Rituals
        such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and
        gain sleep habits.
  The research design is a randomized controlled experimental type study designed to evaluate
        the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on
        children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep
        habits of children in the earthquake area by pre-interviewing the parents of children aged
        3-6. Children aged 3-6 with sleep problems will be divided into control and experimental
        groups according to their scale scores. The part up to this section constitutes the
        preliminary test of our research.
  
        Children aged 3-6 years in the control group and their parents will not receive any
        intervention.
  
        Families of the children in the experimental group will be given a sleep companion gift to
        give to their children. Children's sleep habits scale will be applied as a post-test to
        determine children's sleep problems 15 days after they receive a gift from their sleep
        friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made
        between pretest and posttest mean scores.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Children's Sleep Habits Scale
  time frame: 15 day
  description: The Children's Sleep Habits Scale will be used to determine children's sleep habits and sleep-related problems. Children's Sleep Habits Scale consists of 8 sub-dimensions and a total of 33 items.In grading the scale, parents are asked to respond as 1=rarely (0-1 times a week), 2=sometimes (2-4 times a week), and 3=usually (5-7 times a week). A minimum of 33 points and a maximum of 99 points are taken from the scale. The total test score is obtained by summing the scores obtained from the items one by one.
  It is accepted that those who have a total score of 41 and above with CIAS have clinical sleep problems.
  arm group label: Experimental group
  arm group type: Experimental
  description: Children in the experimental group will be given a sleeping companion toy.
  arm group label: Control group
  arm group type: No Intervention
  description: No intervention will be made on the control group.
  intervention type: Other
  intervention name: sleep toy
  description: The parents of the children in the experimental group will be given a sleeping companion toy to present to their children. At the end of 15 days, the Children's Sleep Habits scale will be applied as a post-test to evaluate the effect of the sleep companion toy.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: FATMA KURUDİREK
  role: Principal Investigator
  affiliation: fsaban@atauni.edu.tr
  last name: Türkan KADİROĞLU
  role: Principal Investigator
  affiliation: t.kadiroglu@atauni.edu.tr
  last name: Elif Simay KOÇ
  phone: 05071499746
  email: elifsimay.koc@kilis.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Kilis 7 Aralik University
  investigator full name: Elif Simay KOÇ
  investigator title: Lecturer
  sharing ipd: No