<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/NCT02992626</url>
  </required_header>
  <id_info>
    <org_study_id>HAI1</org_study_id>
    <nct_id>NCT02992626</nct_id>
  </id_info>
  <brief_title>Influence of Dogs on Learning in Children</brief_title>
  <official_title>Influence of Interacting With Dogs on Learning in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Tropical &amp; Public Health Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Tropical &amp; Public Health Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a randomised controlled cross-over study, the influence of interacting with a dog on&#xD;
      children's learning performance is investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VLMT (Verbaler Lern- und Merkfähigkeitstest)</measure>
    <time_frame>20 Minutes</time_frame>
    <description>Number of remembered items within the test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Digit Span (from HAWIK-IV)</measure>
    <time_frame>5 Minutes</time_frame>
    <description>Number of remembered items (auditively presented numbers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motoric task (from Kaufman Assessment Battery for Children, dt. Version (K-ABC))</measure>
    <time_frame>5 Minutes</time_frame>
    <description>Number of remembered items (visually presented gestures) that can be reproduced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate/heart rate variability</measure>
    <time_frame>60 Minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Learning</condition>
  <condition>Human-animal Interaction</condition>
  <arm_group>
    <arm_group_label>starting with dog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm complete the first session in the presence of a dog. The second session is under control condition in the presence of a stuffed toy dog.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>starting with control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm complete the first session under control condition in the presence of a stuffed toy dog while the second session the tests are completed in the presence of a dog.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human-dog interaction</intervention_name>
    <description>The tests are completed in the presence of a dog. Further, before starting the tests, the children have 15 minutes to interact with the present dog.</description>
    <arm_group_label>starting with control</arm_group_label>
    <arm_group_label>starting with dog</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stuffed toy dog</intervention_name>
    <description>The tests are completed in the presence of a stuffed toy dog. Further, before starting the tests, the children have 15 minutes to play with the stuffed toy dog.</description>
    <arm_group_label>starting with control</arm_group_label>
    <arm_group_label>starting with dog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  7 - 14 years old&#xD;
&#xD;
          -  willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical or psychiatric diagnosis&#xD;
&#xD;
          -  medication&#xD;
&#xD;
          -  allergia (dogs)&#xD;
&#xD;
          -  phobia (dogs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karin Hediger, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Swiss TPH / University of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Tropical &amp; Public Health Institute</investigator_affiliation>
    <investigator_full_name>Karin Hediger</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT02992626
org study id: HAI1
nct id: NCT02992626
lead sponsor: 
collaborator: 
has dmc: No
In a randomised controlled cross-over study, the influence of interacting with a dog on
      children's learning performance is investigated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: VLMT (Verbaler Lern- und Merkfähigkeitstest)
time frame: 20 Minutes
description: Number of remembered items within the test
measure: Digit Span (from HAWIK-IV)
time frame: 5 Minutes
description: Number of remembered items (auditively presented numbers)
measure: motoric task (from Kaufman Assessment Battery for Children, dt. Version (K-ABC))
time frame: 5 Minutes
description: Number of remembered items (visually presented gestures) that can be reproduced.
measure: Heart rate/heart rate variability
time frame: 60 Minutes
arm group label: starting with dog
arm group type: Experimental
description: Participants in this arm complete the first session in the presence of a dog. The second session is under control condition in the presence of a stuffed toy dog.
arm group label: starting with control
arm group type: Experimental
description: Participants in this arm complete the first session under control condition in the presence of a stuffed toy dog while the second session the tests are completed in the presence of a dog.
intervention type: Other
intervention name: Human-dog interaction
description: The tests are completed in the presence of a dog. Further, before starting the tests, the children have 15 minutes to interact with the present dog.
arm group label: starting with control
arm group label: starting with dog
intervention type: Other
intervention name: Stuffed toy dog
description: The tests are completed in the presence of a stuffed toy dog. Further, before starting the tests, the children have 15 minutes to play with the stuffed toy dog.
arm group label: starting with control
arm group label: starting with dog
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karin Hediger, Dr.
role: Study Director
affiliation: Swiss TPH / University of Basel
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Swiss Tropical & Public Health Institute
investigator full name: Karin Hediger
investigator title: Principal Investigator