<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/NCT02201680</url>
  </required_header>
  <id_info>
    <org_study_id>15112005</org_study_id>
    <secondary_id>31130</secondary_id>
    <nct_id>NCT02201680</nct_id>
  </id_info>
  <brief_title>Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation</brief_title>
  <official_title>Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.&#xD;
&#xD;
        2. Several factors defined to effect the anxiety levels preoperatively in children such as&#xD;
           , age, previous medical encounters , education level and parental anxiety. 3. This&#xD;
           information was tested for Turkish children during the preoperative anesthetic&#xD;
           evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Before the planned surgery all children accompanying parents filled a questionnaire&#xD;
           about the demographics, marital status, economical conditions, education level and other&#xD;
           diseases and operations in the family.&#xD;
&#xD;
        2. Both the parent and child filled State and Trait Anxiety tests specially prepared for&#xD;
           adults Spielberger Anxiety tests and children defined and validation tests had already&#xD;
           been proven.&#xD;
&#xD;
      Statistical analysis performed for evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>children state anxiety</measure>
    <time_frame>1 hour</time_frame>
    <description>Anxiety scores were filled within 1 hour no further evalution was performed.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Anxiety State</condition>
  <condition>Parent</condition>
  <condition>Child</condition>
  <arm_group>
    <arm_group_label>parents and children</arm_group_label>
    <description>Anxiety tests</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children planned to undergo surgical procedures or diagnostic procedures under general&#xD;
        anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Legible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illegible due to lack of education or eye diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rovnat Babazade, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University Cerrahpaşa Medical Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Levent Kayaalp, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Private Practice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gurcan Gungor, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Burak Dogangun, Asoc. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Prof. Dr. A. Pervin SUTAS BOZKURT</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>preoperative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02201680
org study id: 15112005
secondary id: 31130
nct id: NCT02201680
lead sponsor: 
has dmc: Yes
1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.

        2. Several factors defined to effect the anxiety levels preoperatively in children such as
           , age, previous medical encounters , education level and parental anxiety. 3. This
           information was tested for Turkish children during the preoperative anesthetic
           evaluation.
1. Before the planned surgery all children accompanying parents filled a questionnaire
           about the demographics, marital status, economical conditions, education level and other
           diseases and operations in the family.

        2. Both the parent and child filled State and Trait Anxiety tests specially prepared for
           adults Spielberger Anxiety tests and children defined and validation tests had already
           been proven.

      Statistical analysis performed for evaluation.
observational model: Cohort
time perspective: Prospective
measure: children state anxiety
time frame: 1 hour
description: Anxiety scores were filled within 1 hour no further evalution was performed.
arm group label: parents and children
description: Anxiety tests
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rovnat Babazade, M.D.
role: Principal Investigator
affiliation: Istanbul University Cerrahpaşa Medical Faculty
last name: Levent Kayaalp, Prof. Dr.
role: Principal Investigator
affiliation: Private Practice
last name: Gurcan Gungor, M.D.
role: Principal Investigator
affiliation: Istanbul University
last name: Burak Dogangun, Asoc. Prof
role: Principal Investigator
affiliation: Istanbul University
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Prof. Dr. A. Pervin SUTAS BOZKURT
investigator title: Prof. Dr.
mesh term: Anxiety Disorders