<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/NCT02199587</url>
  </required_header>
  <id_info>
    <org_study_id>MeirMc069-14CTIL</org_study_id>
    <nct_id>NCT02199587</nct_id>
  </id_info>
  <brief_title>The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test</brief_title>
  <official_title>The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators would like to examine the contribution of medical clowns in routine medical&#xD;
      procedures in the endocrine clinic. This will be the first time that will objective evaluate&#xD;
      the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and&#xD;
      also evaluate the effect of mental stress on growth hormone secretion in children.&#xD;
&#xD;
      The aim of the current study is testing the pain and anxiety of the patient and the&#xD;
      accompanying parent and medical staff in the presence or absence of medical clown at the&#xD;
      time:&#xD;
&#xD;
        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.&#xD;
&#xD;
        2. Growth hormone tests.&#xD;
&#xD;
      Secondary end point will be:&#xD;
&#xD;
        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone&#xD;
           tests in the presence of a clown.&#xD;
&#xD;
        2. Does the presence of a medical clown and the mental stress affect the secretion of&#xD;
           growth hormone?&#xD;
&#xD;
        3. Are there differences in growth hormone secretion and stress hormones between the&#xD;
           various tests for growth hormone secretion (glucagon, clonidine or arginine) in the&#xD;
           presence of a clown?&#xD;
&#xD;
        4. Are there differences in response to stress and the secretion of growth hormone in&#xD;
           children with obesity?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 children from the endocrine clinic who are referred for treatment with LRH analog or&#xD;
      directed to growth hormone tests, will take part in the study:&#xD;
&#xD;
      1.40 children who are referred to decapeptyl treatment will receive the injection once with a&#xD;
      medical clown, and the next time with out the clown and vise verse. The pain and anxiety&#xD;
      perception of the child and caregivers will be compare between the two scenarios. The&#xD;
      children will be randomly assigned to begin treatment in the presence of a clown and the next&#xD;
      injection without medical clown and the second group starts the injections without medical&#xD;
      clown and the next shot in the presence of a clown.&#xD;
&#xD;
      2.40 children from endocrine clinic who are referred for growth hormone tests because of&#xD;
      short stature will have the test with or without medical clown in a random selection.&#xD;
&#xD;
      Procedure&#xD;
&#xD;
        1. Children who receive decapeptyl injections once a month. Before getting the shot will be&#xD;
           offered to participate in the study. After signing the consent form and parent consent&#xD;
           they randomized to get the treatment in the presence of a clown or without health.&#xD;
&#xD;
        2. The kids and their parents who referred to growth hormone test will be offered to&#xD;
           participate in the study and after signing the consent will be invited for the test.&#xD;
           According to accepted protocol, the children arrived after overnight fast, an&#xD;
           intravenous line is inserted and blood is taken for measurement of human growth hormone&#xD;
           levels, IGF1, thyroid function test, prolactin, cortisol, and adrenaline and then a&#xD;
           stimulates substance (glucagon, clonidine or arginine) is given. Afterward blood tests&#xD;
           for human growth hormone and cortisol levels, are taken every 30-60 minutes for&#xD;
           approximately 3-4 hours after administration of the provocative substance. During the&#xD;
           test regular vital signs are monitored according to Protocol.&#xD;
&#xD;
      In both procedures, anxiety of the child and his parent will be evaluated by questionnaires.&#xD;
      State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the&#xD;
      kids. In addition, the kid, his parent and the medical staff will evaluate for pain by Visual&#xD;
      Analog Score (VAS).&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Children older than 4 years.&#xD;
&#xD;
        -  referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.&#xD;
&#xD;
      The criteria included:&#xD;
&#xD;
      • The consent of a parent and the child to participate in a study&#xD;
&#xD;
      Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)&#xD;
&#xD;
      Pain assessment scale:&#xD;
&#xD;
      Pain assessment by the child, the parents and the staff (VAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2014</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 16, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids.</measure>
    <time_frame>At 30 min before the procedure and 30 min after the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown.</measure>
    <time_frame>At 30 min before the test and 30 min after the test</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Precocious Puberty</condition>
  <condition>Growth Hormone Tests</condition>
  <arm_group>
    <arm_group_label>Endocrine test with medical clown</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>children who are referred to endocrine test will have the procedure with a medical clown, or without. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endocrine test without medical clown</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Presence of medical clown during endocrine test</intervention_name>
    <arm_group_label>Endocrine test with medical clown</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children older than 4 years. referred by the endocrine clinic to a decapeptyl&#xD;
             treatment or growth hormone test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nitsan dror, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical Center endocrine unit</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>June 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical clown</keyword>
  <keyword>Growth hormone</keyword>
  <keyword>Precocious puberty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puberty, Precocious</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/NCT02199587
org study id: MeirMc069-14CTIL
nct id: NCT02199587
lead sponsor: 
has dmc: No
The investigators would like to examine the contribution of medical clowns in routine medical
      procedures in the endocrine clinic. This will be the first time that will objective evaluate
      the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and
      also evaluate the effect of mental stress on growth hormone secretion in children.

      The aim of the current study is testing the pain and anxiety of the patient and the
      accompanying parent and medical staff in the presence or absence of medical clown at the
      time:

        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.

        2. Growth hormone tests.

      Secondary end point will be:

        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone
           tests in the presence of a clown.

        2. Does the presence of a medical clown and the mental stress affect the secretion of
           growth hormone?

        3. Are there differences in growth hormone secretion and stress hormones between the
           various tests for growth hormone secretion (glucagon, clonidine or arginine) in the
           presence of a clown?

        4. Are there differences in response to stress and the secretion of growth hormone in
           children with obesity?
80 children from the endocrine clinic who are referred for treatment with LRH analog or
      directed to growth hormone tests, will take part in the study:

      1.40 children who are referred to decapeptyl treatment will receive the injection once with a
      medical clown, and the next time with out the clown and vise verse. The pain and anxiety
      perception of the child and caregivers will be compare between the two scenarios. The
      children will be randomly assigned to begin treatment in the presence of a clown and the next
      injection without medical clown and the second group starts the injections without medical
      clown and the next shot in the presence of a clown.

      2.40 children from endocrine clinic who are referred for growth hormone tests because of
      short stature will have the test with or without medical clown in a random selection.

      Procedure

        1. Children who receive decapeptyl injections once a month. Before getting the shot will be
           offered to participate in the study. After signing the consent form and parent consent
           they randomized to get the treatment in the presence of a clown or without health.

        2. The kids and their parents who referred to growth hormone test will be offered to
           participate in the study and after signing the consent will be invited for the test.
           According to accepted protocol, the children arrived after overnight fast, an
           intravenous line is inserted and blood is taken for measurement of human growth hormone
           levels, IGF1, thyroid function test, prolactin, cortisol, and adrenaline and then a
           stimulates substance (glucagon, clonidine or arginine) is given. Afterward blood tests
           for human growth hormone and cortisol levels, are taken every 30-60 minutes for
           approximately 3-4 hours after administration of the provocative substance. During the
           test regular vital signs are monitored according to Protocol.

      In both procedures, anxiety of the child and his parent will be evaluated by questionnaires.
      State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the
      kids. In addition, the kid, his parent and the medical staff will evaluate for pain by Visual
      Analog Score (VAS).

      Inclusion criteria:

        -  Children older than 4 years.

        -  referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.

      The criteria included:

      • The consent of a parent and the child to participate in a study

      Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)

      Pain assessment scale:

      Pain assessment by the child, the parents and the staff (VAS).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids.
time frame: At 30 min before the procedure and 30 min after the procedure
measure: Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown.
time frame: At 30 min before the test and 30 min after the test
arm group label: Endocrine test with medical clown
arm group type: Active Comparator
description: children who are referred to endocrine test will have the procedure with a medical clown, or without. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios
arm group label: Endocrine test without medical clown
arm group type: No Intervention
intervention type: Behavioral
intervention name: Presence of medical clown during endocrine test
arm group label: Endocrine test with medical clown
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: nitsan dror, MD
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Puberty, Precocious