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

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT03042728
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Study Start: 2017-09-07
• Primary Completion: 2018-10-20
• Study Completion: 2018-10-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score	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

Name	Time	Method
Change in Pain Intensity Score (Numeric Rating Scale (NRS))	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	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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States