<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/NCT03018145</url>
  </required_header>
  <id_info>
    <org_study_id>CNUH-2016-185</org_study_id>
    <nct_id>NCT03018145</nct_id>
  </id_info>
  <brief_title>Effect of Transportation Method on Preoperative Anxiety in Children</brief_title>
  <official_title>Effect of Transportation Method on Preoperative Anxiety in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <brief_summary>
    <textblock>
      To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car&#xD;
      for reducing preoperative children's anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">April 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 25, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale</measure>
    <time_frame>From entry of operating room to induction of anesthesia</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Anxiety</condition>
  <condition>Child Behavior</condition>
  <arm_group>
    <arm_group_label>Standard stretcher group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use a standard stretcher car as a transporting method in the operating room</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wagon group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use a wagon as a transporting method in the operating room</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wagon</intervention_name>
    <arm_group_label>Wagon group</arm_group_label>
    <other_name>wagonTM, Step 2 company</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard stretcher car</intervention_name>
    <arm_group_label>Standard stretcher group</arm_group_label>
    <other_name>Stryker, Stryker medical</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist physical status I&#xD;
&#xD;
          -  scheduled for elective surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of anesthesia or surgery&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  weighing over than 38kg&#xD;
&#xD;
          -  severe pain&#xD;
&#xD;
          -  administrated psychotomimetic drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>505-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>December 29, 2017</last_update_submitted>
  <last_update_submitted_qc>December 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Seongtae Jeong</investigator_full_name>
    <investigator_title>Department of Anesthesiolgoy and Pain Medicine</investigator_title>
  </responsible_party>
  <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/NCT03018145
org study id: CNUH-2016-185
nct id: NCT03018145
lead sponsor: 
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car
      for reducing preoperative children's anxiety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale
time frame: From entry of operating room to induction of anesthesia
arm group label: Standard stretcher group
arm group type: Experimental
description: Use a standard stretcher car as a transporting method in the operating room
arm group label: Wagon group
arm group type: Active Comparator
description: Use a wagon as a transporting method in the operating room
intervention type: Device
intervention name: Wagon
arm group label: Wagon group
other name: wagonTM, Step 2 company
intervention type: Device
intervention name: Standard stretcher car
arm group label: Standard stretcher group
other name: Stryker, Stryker medical
criteria: 
gender: All
minimum age: 2 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Seongtae Jeong
investigator title: Department of Anesthesiolgoy and Pain Medicine
mesh term: Anxiety Disorders