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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Dog Interaction; Behavioral: Human Interaction

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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Arya B Mohabbat, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2017
• Primary Completion (ACTUAL): October 20, 2018
• Study Completion (ACTUAL): October 20, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (ESTIMATE): February 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 16-006296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No