Back to resultsImpact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dog Interaction
Human Interaction
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia
Eligibility 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
Sites / Locations
- Mayo Clinic
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dog interaction
Human Interaction
Arm Description
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
Human interaction will be received by patients in addition to usual care of fibromyalgia.
Outcomes
Primary Outcome Measures
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
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))
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
The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03042728
Brief Title
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
October 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dog interaction
Arm Type
Active Comparator
Arm Description
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
Arm Title
Human Interaction
Arm Type
Active Comparator
Arm Description
Human interaction will be received by patients in addition to usual care of fibromyalgia.
Intervention Type
Behavioral
Intervention Name(s)
Dog Interaction
Intervention Description
A therapy dog will visit the patients.
Intervention Type
Behavioral
Intervention Name(s)
Human Interaction
Intervention Description
A human will visit the patients.
Primary Outcome Measure Information:
Title
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
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.
Time Frame
Baseline to 1.5 day
Secondary Outcome Measure Information:
Title
Change in Pain Intensity Score (Numeric Rating Scale (NRS))
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.
Time Frame
Baseline to 1.5 day
Title
Change in Score for Fatigue, Anxiety, and Depression
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.
Time Frame
Baseline to 1.5 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arya B Mohabbat
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
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