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
1 other identifier
interventional
229
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedStudy Start
First participant enrolled
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedJanuary 2, 2019
December 1, 2018
1.1 years
January 31, 2017
December 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (2)
Dog interaction
ACTIVE COMPARATORDog interaction will be received by patients in addition to usual care of fibromyalgia.
Human Interaction
ACTIVE COMPARATORHuman interaction will be received by patients in addition to usual care of fibromyalgia.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55901, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arya B Mohabbat
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 3, 2017
Study Start
September 7, 2017
Primary Completion
October 20, 2018
Study Completion
October 20, 2018
Last Updated
January 2, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share