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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Dog Interaction
* Behavioral: Human Interaction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dog interaction<br>Dog interaction will be received by patients in addition to usual care of fibromyalgia. | Behavioral: Dog Interaction<br>* A therapy dog will visit the patients.<br>|
| Active Comparator: Human Interaction<br>Human interaction will be received by patients in addition to usual care of fibromyalgia. | Behavioral: Human Interaction<br>* A human will visit the patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 1.5 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 1.5 day | 
| 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. | Baseline to 1.5 day |