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Clinical Trials/NCT03042728
NCT03042728
Completed
Not Applicable

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

Mayo Clinic2 sites in 1 country229 target enrollmentSeptember 7, 2017
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Mayo Clinic
Enrollment
229
Locations
2
Primary Endpoint
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2017
End Date
October 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arya B. Mohabbat, M.D.

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score

Time Frame: 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 Outcomes

  • Change in Pain Intensity Score (Numeric Rating Scale (NRS))(Baseline to 1.5 day)
  • Change in Score for Fatigue, Anxiety, and Depression(Baseline to 1.5 day)

Study Sites (2)

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