<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/NCT02192710</url>
  </required_header>
  <id_info>
    <org_study_id>2013.794</org_study_id>
    <nct_id>NCT02192710</nct_id>
  </id_info>
  <brief_title>Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam</brief_title>
  <acronym>IPAD</acronym>
  <official_title>Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale:&#xD;
&#xD;
      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug&#xD;
      premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so&#xD;
      coordination between departments and operating room, exposed to the risks of side effects and&#xD;
      failure and this variability action. Alternative means were evaluated, such as the presence&#xD;
      of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.&#xD;
&#xD;
      Electronic tabs are small devices; light, easy to use with age-specific and interactive&#xD;
      programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety&#xD;
      and distract children compare to preoperative medication.&#xD;
&#xD;
      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10&#xD;
      years old programmed for a short term and low level of pain outpatient surgery. My pass score&#xD;
      will be measured when arriving at the hospital, at the time of the separation with the&#xD;
      parents, at the time of the anaesthetic mask induction and after the surgery.&#xD;
&#xD;
      118 patients will be randomized as follows :&#xD;
&#xD;
        -  Arm 1 : Hypnovel® (midazolam)&#xD;
&#xD;
        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon&#xD;
           area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</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>Patient's level of anxiety</measure>
    <time_frame>at day 1</time_frame>
    <description>Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's level of anxiety</measure>
    <time_frame>At day 1</time_frame>
    <description>Comparison of m-YPAS score between the 2 arms&#xD;
when arriving at the operating room airlock H-1 before surgery,&#xD;
at the time of the separation with the parents&#xD;
15 minutes before surgery and&#xD;
30 minutes before departure from the hospital the same day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' level of anxiety</measure>
    <time_frame>At Day 1</time_frame>
    <description>Evaluation of parents anxiety will be assessed by State-Trait Anxiety Inventory (STAI) :&#xD;
when arriving at the operating room airlock H-1 before surgery,&#xD;
at the time of the separation with the parents&#xD;
15 minutes before surgery and&#xD;
30 minutes before departure from the hospital the same day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' level of anxiety</measure>
    <time_frame>Up to 2 weeks after Day 1</time_frame>
    <description>post-surgery behavioral changes will be measured using the Post Hospitalization Behavioral Questionnaire (PHBQ) at Day+1, day+7 and Day+14 after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients, parents and medical team</measure>
    <time_frame>at day 1</time_frame>
    <description>Evaluation of the general satisfaction of children, parents and anesthetic staff will be measured using Visual Analogic Scale (VAS) 30 minutes before departure from the hospital the same day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Paediatric Outpatient Surgery</condition>
  <arm_group>
    <arm_group_label>Hypnovel® (midazolam)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Midazolam oral intake before anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic tab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>electronic tab</intervention_name>
    <description>classic use of an electronic tab with age specific games</description>
    <arm_group_label>Electronic tab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam oral intake</intervention_name>
    <arm_group_label>Hypnovel® (midazolam)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Girls and boys aged 4 to 10 years,&#xD;
&#xD;
          -  American Society of Anesthesiologists Score between 1 and 3,&#xD;
&#xD;
          -  programmed outpatient surgery for a short term and low level of pain&#xD;
&#xD;
          -  Infection with influenza A virus confirmed with a quick diagnostic test,&#xD;
&#xD;
          -  informed consent from both parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 4 or older than 10 years old&#xD;
&#xD;
          -  preexisting psychiatric disorder with pedo-psychiatric follow-up&#xD;
&#xD;
          -  children with intellectual disability&#xD;
&#xD;
          -  psychotropic referred to anxiolytic and / or antipsychotic&#xD;
&#xD;
          -  history of surgery (n&gt;=3)&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>April 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>outpatient surgery</keyword>
  <keyword>anaesthesia</keyword>
  <keyword>midazolam</keyword>
  <keyword>electronic tab</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_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/NCT02192710
org study id: 2013.794
nct id: NCT02192710
lead sponsor: 
has dmc: No
Rationale:

      The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug
      premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so
      coordination between departments and operating room, exposed to the risks of side effects and
      failure and this variability action. Alternative means were evaluated, such as the presence
      of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.

      Electronic tabs are small devices; light, easy to use with age-specific and interactive
      programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety
      and distract children compare to preoperative medication.

      Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10
      years old programmed for a short term and low level of pain outpatient surgery. My pass score
      will be measured when arriving at the hospital, at the time of the separation with the
      parents, at the time of the anaesthetic mask induction and after the surgery.

      118 patients will be randomized as follows :

        -  Arm 1 : Hypnovel® (midazolam)

        -  Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon
           area.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient's level of anxiety
time frame: at day 1
description: Comparison of m-YPAS score between the 2 arms at the time of anaesthetic mask induction (H0)
measure: Patient's level of anxiety
time frame: At day 1
description: Comparison of m-YPAS score between the 2 arms
when arriving at the operating room airlock H-1 before surgery,
at the time of the separation with the parents
15 minutes before surgery and
30 minutes before departure from the hospital the same day
measure: Parents' level of anxiety
time frame: At Day 1
description: Evaluation of parents anxiety will be assessed by State-Trait Anxiety Inventory (STAI) :
when arriving at the operating room airlock H-1 before surgery,
at the time of the separation with the parents
15 minutes before surgery and
30 minutes before departure from the hospital the same day
measure: Parents' level of anxiety
time frame: Up to 2 weeks after Day 1
description: post-surgery behavioral changes will be measured using the Post Hospitalization Behavioral Questionnaire (PHBQ) at Day+1, day+7 and Day+14 after surgery
measure: Satisfaction of patients, parents and medical team
time frame: at day 1
description: Evaluation of the general satisfaction of children, parents and anesthetic staff will be measured using Visual Analogic Scale (VAS) 30 minutes before departure from the hospital the same day
arm group label: Hypnovel® (midazolam)
arm group type: Active Comparator
description: Midazolam oral intake before anesthesia
arm group label: Electronic tab
arm group type: Experimental
intervention type: Procedure
intervention name: electronic tab
description: classic use of an electronic tab with age specific games
arm group label: Electronic tab
intervention type: Drug
intervention name: Midazolam oral intake
arm group label: Hypnovel® (midazolam)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Midazolam