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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03042728
Enrollment
229
Registered
2017-02-03
Start date
2017-09-07
Completion date
2018-10-20
Last updated
2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Interventions

BEHAVIORALDog Interaction

A therapy dog will visit the patients.

BEHAVIORALHuman Interaction

A human will visit the patients.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) scoreBaseline to 1.5 dayThe 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

MeasureTime frameDescription
Change in Pain Intensity Score (Numeric Rating Scale (NRS))Baseline to 1.5 dayThe 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 DepressionBaseline to 1.5 dayThe subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026