<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/NCT02185976</url>
  </required_header>
  <id_info>
    <org_study_id>2013/051</org_study_id>
    <nct_id>NCT02185976</nct_id>
  </id_info>
  <brief_title>Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.</brief_title>
  <official_title>Preoperative Anxiety in Paediatric Patients; do Cartoons Help?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balikesir University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balikesir University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a&#xD;
      special group who need special attention. Some studies have shown that cartoons are a very&#xD;
      good tool for distraction in the preoperative period for children.&#xD;
&#xD;
      Our hypothesis is that children watching Cartoons in the preoperative period will have less&#xD;
      anxiety and will be fit with preparation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After local ethics committee approval 60 patients scheduled for various types of surgery will&#xD;
      be included.&#xD;
&#xD;
      On the operation day patients are going to be evaluated in the preoperative preparation room.&#xD;
      For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this&#xD;
      first evaluation patients are going to be separated randomly into two groups; group R&#xD;
      (routine) and group C (cartoon). All patients are going to be premedicated with midazolam.&#xD;
      The first group will receive their premedication straight after the first evaluation and&#xD;
      their response will be recorded as easy, moderate, difficult, does not accept. Group C will&#xD;
      choose a cartoon movie (5 different movies are recorded and will be shown through a tablet&#xD;
      PC)) and will begin to watch it. After 5 minutes they will receive their premedication and&#xD;
      their response will also be recorded. After 30 minutes a physician will try to insert an IV&#xD;
      line and the response of the child will also be evaluated and recorded as easy, moderate,&#xD;
      difficult and does not allow. Afterwards the patient will be transported into the operation&#xD;
      room. In the operation room anesthesia will be induced via Sevoflurane and the response to&#xD;
      mask anesthesia will be evaluated with the mask score as it is described before in previous&#xD;
      studies. Patients in Group C will continue to watch the cartoon movie until the induction of&#xD;
      anesthesia. And the modified yale score will also be reevaluated and recorded.&#xD;
&#xD;
      The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.&#xD;
&#xD;
      The family and the child will also be interviewed separately, 4 prepared standard questions&#xD;
      will be asked in order to understand how the family described the operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anxiety score</measure>
    <time_frame>at the beginning and before induction of anesthesia</time_frame>
    <description>the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>family anxiety scores</measure>
    <time_frame>Before operation during the first examination</time_frame>
    <description>the anxiety score of the parents is going to be evaluated before the operation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>cartoon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>routine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>paediatric patients undergoing general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cartoon</intervention_name>
    <description>5 different cartoons which will be recorded on a tablet PC.</description>
    <arm_group_label>cartoon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  family approval&#xD;
&#xD;
          -  age between 3-9&#xD;
&#xD;
          -  scheduled for surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of physiatric disease&#xD;
&#xD;
          -  regular medication&#xD;
&#xD;
          -  previous history of anesthesia/sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hafize Fi Demir, Assist. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balikesir University School of Medicine Department of Anesthesia and Reanimation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Balikesir University Faculty of Medicine</name>
      <address>
        <city>Balikesir</city>
        <zip>10145</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Balikesir University</investigator_affiliation>
    <investigator_full_name>hafize fisun demir</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>preoperative anxiety</keyword>
  <keyword>paediatric patients</keyword>
  <keyword>Cartoon</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/NCT02185976
org study id: 2013/051
nct id: NCT02185976
lead sponsor: 
has dmc: No
Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a
      special group who need special attention. Some studies have shown that cartoons are a very
      good tool for distraction in the preoperative period for children.

      Our hypothesis is that children watching Cartoons in the preoperative period will have less
      anxiety and will be fit with preparation.
After local ethics committee approval 60 patients scheduled for various types of surgery will
      be included.

      On the operation day patients are going to be evaluated in the preoperative preparation room.
      For anxiety evaluation the modified yale preoperative anxiety scale will be used. After this
      first evaluation patients are going to be separated randomly into two groups; group R
      (routine) and group C (cartoon). All patients are going to be premedicated with midazolam.
      The first group will receive their premedication straight after the first evaluation and
      their response will be recorded as easy, moderate, difficult, does not accept. Group C will
      choose a cartoon movie (5 different movies are recorded and will be shown through a tablet
      PC)) and will begin to watch it. After 5 minutes they will receive their premedication and
      their response will also be recorded. After 30 minutes a physician will try to insert an IV
      line and the response of the child will also be evaluated and recorded as easy, moderate,
      difficult and does not allow. Afterwards the patient will be transported into the operation
      room. In the operation room anesthesia will be induced via Sevoflurane and the response to
      mask anesthesia will be evaluated with the mask score as it is described before in previous
      studies. Patients in Group C will continue to watch the cartoon movie until the induction of
      anesthesia. And the modified yale score will also be reevaluated and recorded.

      The family anxiety will be evaluated with the State Trait Anxiety Inventory Scale.

      The family and the child will also be interviewed separately, 4 prepared standard questions
      will be asked in order to understand how the family described the operation.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: anxiety score
time frame: at the beginning and before induction of anesthesia
description: the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction.
measure: family anxiety scores
time frame: Before operation during the first examination
description: the anxiety score of the parents is going to be evaluated before the operation.
arm group label: cartoon
arm group type: Active Comparator
description: paediatric patients undergoing general anesthesia. This group will choose a cartoon movie to watch throughout the preparation until the induction of anesthesia
arm group label: routine
arm group type: No Intervention
description: paediatric patients undergoing general anesthesia
intervention type: Other
intervention name: cartoon
description: 5 different cartoons which will be recorded on a tablet PC.
arm group label: cartoon
criteria: 
gender: All
minimum age: 3 Years
maximum age: 9 Years
healthy volunteers: No
last name: Hafize Fi Demir, Assist. Prof
role: Principal Investigator
affiliation: Balikesir University School of Medicine Department of Anesthesia and Reanimation
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Balikesir University
investigator full name: hafize fisun demir
investigator title: Assistant Professor
mesh term: Anxiety Disorders