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Completed

NCT Number: NCT03042728

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dog Interaction

Behavioral

A therapy dog will visit the patients.

Human Interaction

Behavioral

A human will visit the patients.

Primary outcomes

  1. 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

  1. Change in Pain Intensity Score (Numeric Rating Scale (NRS))

    Time frame: Baseline to 1.5 day

    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.

  2. Change in Score for Fatigue, Anxiety, and Depression

    Time frame: Baseline to 1.5 day

    The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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