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

Mayo Clinic229 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

229

Conditions

Fibromyalgia

Interventions

Dog InteractionBEHAVIORAL

A therapy dog will visit the patients.

Human InteractionBEHAVIORAL

A human will visit the patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Rochester, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 1.5 day

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline to 1.5 day

Data from ClinicalTrials.gov

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