<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/NCT04502836</url>
  </required_header>
  <id_info>
    <org_study_id>RMC028220ctil</org_study_id>
    <nct_id>NCT04502836</nct_id>
  </id_info>
  <brief_title>Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study</brief_title>
  <official_title>Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 20% of the population is reporting on &quot;white coat syndrome&quot;, manifested as anxiety&#xD;
      symptoms and elevated BP during interaction with medical staff. It is estimated that,&#xD;
      throughout the life span of children, approximately 15-20% will suffer from some form of a&#xD;
      trauma relating to an interaction with health provider. The proposed study aims is to&#xD;
      evaluate the correlation between a single preliminary psychological intervention, including&#xD;
      providing knowledge and tools for problems solving, and the anxiety level in female patients&#xD;
      arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in&#xD;
      comparison to the anxiety in patients arriving to the same test without psychological&#xD;
      intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment&#xD;
      (performed as part of routine medical care) will be recruited to the study and will be&#xD;
      randomized to one of 2 groups. Participants in the intervention group (10 patients) will be&#xD;
      required to arrive with their parents an hour prior to the test and will receive a&#xD;
      preliminary psychological intervention. The control group will arrive to the ACTH LRH test on&#xD;
      the scheduled time and will not receive psychological intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety Questionnaire</measure>
    <time_frame>Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parents Treatment Satisfaction Questionnaire</measure>
    <time_frame>Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Precocious Puberty</condition>
  <arm_group>
    <arm_group_label>preliminary psychological intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will not receive any psychological intervention prior to the test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preliminary psychological intervention</intervention_name>
    <description>psychological intervention including providing knowledge and tools for problems solving according to the Choice - Agenda - Resilience - Emotional support (CARE) model . After intervention session patients and their parents will be asked to complete questionnaires</description>
    <arm_group_label>preliminary psychological intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Girls referred to ACTH LRH or LRH test&#xD;
&#xD;
          -  Age 7-12 years old&#xD;
&#xD;
          -  Ability to answer questionnaire independently (hebrew language only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental disability&#xD;
&#xD;
          -  Girls who were referred to the test in purpose of evaluation of the pituitary adrenal&#xD;
             axis after prolong steroids therapy.&#xD;
&#xD;
          -  Girls with chronic disease that required frequent hospitalization (over 4 times per&#xD;
             year)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moshe Phillip, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moshe Phillip, Prof</last_name>
    <phone>972-54-4795995</phone>
    <email>moshe.phillip@phillipmd.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naama Glikman, BSc</last_name>
    <phone>972-3-9253833</phone>
    <email>naamagl@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naama Glikman, BSc</last_name>
      <phone>972-3-9253833</phone>
      <email>naamagl@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Moshe Phillip, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alon Liberman, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rotem Diamant, Msc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>February 21, 2022</last_update_submitted>
  <last_update_submitted_qc>February 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ACTH LRH Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puberty, Precocious</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04502836
org study id: RMC028220ctil
nct id: NCT04502836
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over 20% of the population is reporting on "white coat syndrome", manifested as anxiety
      symptoms and elevated BP during interaction with medical staff. It is estimated that,
      throughout the life span of children, approximately 15-20% will suffer from some form of a
      trauma relating to an interaction with health provider. The proposed study aims is to
      evaluate the correlation between a single preliminary psychological intervention, including
      providing knowledge and tools for problems solving, and the anxiety level in female patients
      arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in
      comparison to the anxiety in patients arriving to the same test without psychological
      intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment
      (performed as part of routine medical care) will be recruited to the study and will be
      randomized to one of 2 groups. Participants in the intervention group (10 patients) will be
      required to arrive with their parents an hour prior to the test and will receive a
      preliminary psychological intervention. The control group will arrive to the ACTH LRH test on
      the scheduled time and will not receive psychological intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anxiety Questionnaire
time frame: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
measure: Parents Treatment Satisfaction Questionnaire
time frame: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
arm group label: preliminary psychological intervention
arm group type: Experimental
description: Participants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test.
arm group label: control group
arm group type: No Intervention
description: Participants in this group will not receive any psychological intervention prior to the test.
intervention type: Behavioral
intervention name: Preliminary psychological intervention
description: psychological intervention including providing knowledge and tools for problems solving according to the Choice - Agenda - Resilience - Emotional support (CARE) model . After intervention session patients and their parents will be asked to complete questionnaires
arm group label: preliminary psychological intervention
criteria: 
gender: Female
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Moshe Phillip, Prof
role: Principal Investigator
affiliation: Schneider Children's Medical Center, Israel
last name: Moshe Phillip, Prof
phone: 972-54-4795995
email: moshe.phillip@phillipmd.com
last name: Naama Glikman, BSc
phone: 972-3-9253833
email: naamagl@clalit.org.il
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Puberty, Precocious
sharing ipd: No