<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/NCT03784573</url>
  </required_header>
  <id_info>
    <org_study_id>1811186507</org_study_id>
    <nct_id>NCT03784573</nct_id>
  </id_info>
  <brief_title>Canine-Assisted Anxiety Reduction In Emergency Care</brief_title>
  <acronym>CANINE III</acronym>
  <official_title>Canine-Assisted Anxiety Reduction In Emergency Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</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>
      Compare the effect of a single exposure to a therapy dog and handler within the pediatric&#xD;
      emergency department patient with anxiety by measuring the change in patient perception of&#xD;
      anxiety before and after dog exposure using the FACES scale. We will also measure galvanic&#xD;
      skin response (resistance to electrical current).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study challenges current dogma by introducing a widely available, low cost method of dog&#xD;
      therapy to reduce patient stress. The organization &quot;Paws of Love&quot; estimates that it has&#xD;
      180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer&#xD;
      their time in emergency care. The benefits may include improved perception of wellness, less&#xD;
      opioid use, and decreased use of physical and chemical restraints. As a further&#xD;
      extrapolation, this secondary effect may extend to improved patient-doctor communication and&#xD;
      patient experience. This will in turn improve patient safety in the Emergency Department,&#xD;
      decreasing the number of adverse events, and decreasing the risk of medical malpractice by&#xD;
      improving the patient-provider relationship. (6, 7)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anxiety level of subject</measure>
    <time_frame>45 minutes</time_frame>
    <description>Change in anxiety level of subject with the use of the FACES scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of anxiety level from physician</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in perception anxiety level of subject with the use of the FACES scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of pain level from physician</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of anxiety level from parent(s)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of pain level from parent(s)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meds</measure>
    <time_frame>4 hours</time_frame>
    <description>Number of medications used to reduce anxiety in the different arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical restrain use</measure>
    <time_frame>4 hours</time_frame>
    <description>Number of times physical restraints are used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Anxiety</condition>
  <condition>Opioid Use</condition>
  <condition>Children</condition>
  <condition>Therapy Dog</condition>
  <arm_group>
    <arm_group_label>Dog + handler</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No dog</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dog + handler</intervention_name>
    <description>Dog + handler</description>
    <arm_group_label>Dog + handler</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No dog</intervention_name>
    <description>No dog</description>
    <arm_group_label>No dog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4-17 years old;&#xD;
&#xD;
          -  Physician or nurse with primary care responsibilities believes that the patients has a&#xD;
             moderate to high level of anxiety&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - violent behavior and any reported prior fear or adverse reaction to dogs in the dog&#xD;
        intervention group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Huma L Siddiqui, MD</last_name>
    <phone>317-880-3900</phone>
    <email>hksiddiq@iu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate Pettit, MS</last_name>
    <phone>317-880-3900</phone>
    <email>klpettit@iu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IU Health Riley Children's Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cassandra Hall</last_name>
      <phone>317-697-2850</phone>
      <email>clsh@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kate Pettit</last_name>
      <phone>317-962-1190</phone>
      <email>klpettit@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jeffrey Kline, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kimberly Van Ryzin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Heather Kelker</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <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/NCT03784573
org study id: 1811186507
nct id: NCT03784573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the effect of a single exposure to a therapy dog and handler within the pediatric
      emergency department patient with anxiety by measuring the change in patient perception of
      anxiety before and after dog exposure using the FACES scale. We will also measure galvanic
      skin response (resistance to electrical current).
This study challenges current dogma by introducing a widely available, low cost method of dog
      therapy to reduce patient stress. The organization "Paws of Love" estimates that it has
      180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer
      their time in emergency care. The benefits may include improved perception of wellness, less
      opioid use, and decreased use of physical and chemical restraints. As a further
      extrapolation, this secondary effect may extend to improved patient-doctor communication and
      patient experience. This will in turn improve patient safety in the Emergency Department,
      decreasing the number of adverse events, and decreasing the risk of medical malpractice by
      improving the patient-provider relationship. (6, 7)
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in anxiety level of subject
time frame: 45 minutes
description: Change in anxiety level of subject with the use of the FACES scale
measure: Perception of anxiety level from physician
time frame: 60 minutes
description: Change in perception anxiety level of subject with the use of the FACES scale
measure: Perception of pain level from physician
time frame: 60 minutes
description: Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale
measure: Perception of anxiety level from parent(s)
time frame: 60 minutes
description: Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale
measure: Perception of pain level from parent(s)
time frame: 60 minutes
description: Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale
measure: Meds
time frame: 4 hours
description: Number of medications used to reduce anxiety in the different arms
measure: Physical restrain use
time frame: 4 hours
description: Number of times physical restraints are used
arm group label: Dog + handler
arm group type: Active Comparator
arm group label: No dog
arm group type: Placebo Comparator
intervention type: Behavioral
intervention name: Dog + handler
description: Dog + handler
arm group label: Dog + handler
intervention type: Behavioral
intervention name: No dog
description: No dog
arm group label: No dog
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huma L Siddiqui, MD
phone: 317-880-3900
email: hksiddiq@iu.edu
last name: Kate Pettit, MS
phone: 317-880-3900
email: klpettit@iu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Heather Kelker
investigator title: Principal Investigator
mesh term: Emergencies
mesh term: Anxiety Disorders