An interventional study of Dog Interaction and Human Interaction in Fibromyalgia, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
1,370 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 229 is above the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Mayo Clinic is the lead sponsor of 3,264 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Dog Interaction
Human interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Human Interaction
A therapy dog will visit the patients.
A human will visit the patients.
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
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
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Oct 2018, 13 months.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 13 months is close to that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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