<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/NCT03042728</url>
  </required_header>
  <id_info>
    <org_study_id>16-006296</org_study_id>
    <nct_id>NCT03042728</nct_id>
  </id_info>
  <brief_title>Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program</brief_title>
  <official_title>Impact of Inclusion of a Dog as Part of the Fibromyalgia Treatment Program on Patient's Physical and Mental Health Functioning - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      In this study the investigators hypothesize that the presence of a Mayo Clinic certified&#xD;
      therapy dog will provide additional benefits above typical therapy for patients suffering&#xD;
      from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The human animal bond refers an emotional relationship between animals and people. The&#xD;
      purpose of this study is to evaluate whether the presence of a dog provide additional&#xD;
      benefits above typical therapy for patients suffering from fibromyalgia and also to assess&#xD;
      the emotional wellbeing state of the therapy dog.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">October 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 20, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score</measure>
    <time_frame>Baseline to 1.5 day</time_frame>
    <description>The FIQR questionnaire consists of 21 questions in 3 domains. Each question has 11 boxes similar to a visual analog scale, rating the item from no difficulty to very difficult. To score the FIQR, the researcher must sum the answers for each domain. Then the function domain is divided by 3, the overall impact domain remains unchanged, and the symptom domain score is divided by 2. The resulting scores are added, and final score can range from 0 -100, with 0=no difficulty, and 100=great difficulty.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Intensity Score (Numeric Rating Scale (NRS))</measure>
    <time_frame>Baseline to 1.5 day</time_frame>
    <description>The subject is asked to make three pain ratings corresponding to the current, best, and worst pain experienced over the past 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NRS scale consists of numbers 0 through 10, with 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score for Fatigue, Anxiety, and Depression</measure>
    <time_frame>Baseline to 1.5 day</time_frame>
    <description>The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">229</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Dog interaction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dog interaction will be received by patients in addition to usual care of fibromyalgia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Human Interaction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human interaction will be received by patients in addition to usual care of fibromyalgia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dog Interaction</intervention_name>
    <description>A therapy dog will visit the patients.</description>
    <arm_group_label>Dog interaction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Human Interaction</intervention_name>
    <description>A human will visit the patients.</description>
    <arm_group_label>Human Interaction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients diagnosed with Fibromyalgia at our Fibromyalgia Clinic&#xD;
&#xD;
          -  Patients actively being seen at the Fibromyalgia Clinic&#xD;
&#xD;
          -  Able and willing to give informed consent&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Able to complete questionnaires&#xD;
&#xD;
          -  No fear or allergy of dogs&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Diagnoses of bipolar disorder, schizophrenia, or dementia&#xD;
&#xD;
          -  Individuals who decline to participate in the study&#xD;
&#xD;
          -  Individuals that are severely allergic to or fearful of dogs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arya B Mohabbat</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Arya B. Mohabbat, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03042728
org study id: 16-006296
nct id: NCT03042728
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the investigators hypothesize that the presence of a Mayo Clinic certified
      therapy dog will provide additional benefits above typical therapy for patients suffering
      from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.
The human animal bond refers an emotional relationship between animals and people. The
      purpose of this study is to evaluate whether the presence of a dog provide additional
      benefits above typical therapy for patients suffering from fibromyalgia and also to assess
      the emotional wellbeing state of the therapy dog.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
time frame: Baseline to 1.5 day
description: The FIQR questionnaire consists of 21 questions in 3 domains. Each question has 11 boxes similar to a visual analog scale, rating the item from no difficulty to very difficult. To score the FIQR, the researcher must sum the answers for each domain. Then the function domain is divided by 3, the overall impact domain remains unchanged, and the symptom domain score is divided by 2. The resulting scores are added, and final score can range from 0 -100, with 0=no difficulty, and 100=great difficulty.
measure: Change in Pain Intensity Score (Numeric Rating Scale (NRS))
time frame: Baseline to 1.5 day
description: The subject is asked to make three pain ratings corresponding to the current, best, and worst pain experienced over the past 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NRS scale consists of numbers 0 through 10, with 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain.
measure: Change in Score for Fatigue, Anxiety, and Depression
time frame: Baseline to 1.5 day
description: The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.
arm group label: Dog interaction
arm group type: Active Comparator
description: Dog interaction will be received by patients in addition to usual care of fibromyalgia.
arm group label: Human Interaction
arm group type: Active Comparator
description: Human interaction will be received by patients in addition to usual care of fibromyalgia.
intervention type: Behavioral
intervention name: Dog Interaction
description: A therapy dog will visit the patients.
arm group label: Dog interaction
intervention type: Behavioral
intervention name: Human Interaction
description: A human will visit the patients.
arm group label: Human Interaction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Arya B Mohabbat
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Arya B. Mohabbat, M.D.
investigator title: PI
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Yes