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Trial record 6 of 106 for:    fibromyalgia | Open Studies | Interventional Studies

Impact of Inclusion of a Dog as Part of the Fibromyalgia Treatment Program

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Arya B. Mohabbat, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03042728
First received: January 31, 2017
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
In this study the investigators hypothesize that the presence of a dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia.

Condition Intervention
Fibromyalgia
Behavioral: Dog Interaction
Behavioral: Human Interaction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score [ Time Frame: Baseline to 1.5 day ]
    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.


Secondary Outcome Measures:
  • Change in Pain Intensity Score (Numeric Rating Scale (NRS)) [ Time Frame: Baseline to 1.5 day ]
    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.

  • Change in Score for Fatigue, Anxiety, and Depression [ Time Frame: Baseline to 1.5 day ]
    The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.


Estimated Enrollment: 230
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dog interaction
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Dog Interaction
A therapy dog will visit the patients.
Active Comparator: Human Interaction
Human interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Human Interaction
A human will visit the patients.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients diagnosed with Fibromyalgia at our Fibromyalgia Clinic
  • Patients actively being seen at the Fibromyalgia Clinic
  • Able and willing to give informed consent
  • Able to speak English
  • Able to complete questionnaires
  • No fear or allergy of dogs

Exclusion Criteria

  • Diagnoses of bipolar disorder, schizophrenia, or dementia
  • Individuals who decline to participate in the study
  • Individuals that are severely allergic to or fearful of dogs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03042728

Contacts
Contact: Saswati Mahapatra, MS 507-284-5404 Mahapatra.Saswati@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55901
Contact: Arya B Mohabbat, MD    507-284-9039    mohabbat.arya@mayo.edu   
Contact: Saswati Mahapatra, MS    507-284-5404    mahapatra.saswati@mayo.edu   
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Arya B Mohabbat Mayo Clinic
  More Information

Responsible Party: Arya B. Mohabbat, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03042728     History of Changes
Other Study ID Numbers: 16-006296
Study First Received: January 31, 2017
Last Updated: February 1, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on March 29, 2017