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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042728
• Other study ID #: 16-006296
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: October 20, 2018

Study information

• Verified date: December 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 20, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Dog Interaction
A therapy dog will visit the patients.
• Human Interaction
A human will visit the patients.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to 1.5 day
Secondary	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.	Baseline to 1.5 day