<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/NCT01688115</url>
  </required_header>
  <id_info>
    <org_study_id>IPAD2012</org_study_id>
    <nct_id>NCT01688115</nct_id>
  </id_info>
  <brief_title>Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase</brief_title>
  <official_title>Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florence</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of a video shown using an iPad,&#xD;
      compared to a standard treatment, to reduce preoperative anxiety in children who have to&#xD;
      undergo to elective surgery procedure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative anxiety</measure>
    <time_frame>perhaps 24 hours from child admission to surgery procedure</time_frame>
    <description>Preoperative anxiety is measured using the &quot;Modified Yale Preoperative Anxiety Scale (m-YPAS)&quot;</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Preoperative Anxiety</condition>
  <arm_group>
    <arm_group_label>Procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Video</intervention_name>
    <description>The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.</description>
    <arm_group_label>Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 6 and 11&#xD;
&#xD;
          -  No cerebral impairment or cognitive impairment&#xD;
&#xD;
          -  Child and his/her family native speaker of Italian&#xD;
&#xD;
          -  admission to the hospital at list one day before the sugery procedure&#xD;
&#xD;
          -  presence of written consent of the parents to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age lower than 6 or upper than 11&#xD;
&#xD;
          -  presence of cerebral impairment or cognitive impairment&#xD;
&#xD;
          -  Child and his/her family are not native speaker of Italian&#xD;
&#xD;
          -  absence of written consent of the parents to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Florence</investigator_affiliation>
    <investigator_full_name>Filippo Festini</investigator_full_name>
    <investigator_title>Professor of Nursing</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/NCT01688115
org study id: IPAD2012
nct id: NCT01688115
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy of a video shown using an iPad,
      compared to a standard treatment, to reduce preoperative anxiety in children who have to
      undergo to elective surgery procedure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Preoperative anxiety
time frame: perhaps 24 hours from child admission to surgery procedure
description: Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)"
arm group label: Procedure
arm group type: Experimental
arm group label: Standard Care
arm group type: Active Comparator
intervention type: Procedure
intervention name: Video
description: The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.
arm group label: Procedure
intervention type: Other
intervention name: Standard care
description: In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child
arm group label: Standard Care
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Florence
investigator full name: Filippo Festini
investigator title: Professor of Nursing
mesh term: Anxiety Disorders