FibromyalgiaNCT03042728
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
A study testing Dog Interaction and Human Interaction in people with Fibromyalgia, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dog Interaction and Human Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2017to 20 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55901
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Dog Interaction, Human Interaction
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog InteractionBehavioural
A therapy dog will visit the patients.
Human InteractionBehavioural
A human will visit the patients.
| Study group | Role | What they receive |
|---|---|---|
| Dog interaction | Active comparator | Dog interaction will be received by patients in addition to usual care of fibromyalgia. Receives: Behavioral: Dog Interaction |
| Human Interaction | Active comparator | Human interaction will be received by patients in addition to usual care of fibromyalgia. Receives: Behavioral: Human Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1.5 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to 1.5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start7 Sep 2017
- Primary completion20 Oct 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arya B. Mohabbat, M.D., Mayo Clinic
- Investigators
- Arya B Mohabbat, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042728
- Sponsor's protocol ID
- 16-006296
- Status last verified
- Dec 2018
- First submitted
- 31 Jan 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03042728
- Acronym / sponsor ID
- 16-006296
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dog interaction | Active comparator | Behavioral: Dog InteractionDog interaction will be received by patients in addition to usual care of fibromyalgia. |
| Human Interaction | Active comparator | Behavioral: Human InteractionHuman interaction will be received by patients in addition to usual care of fibromyalgia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog InteractionA therapy dog will visit the patients. | Behavioural | Dog interaction |
| Human InteractionA human will visit the patients. | Behavioural | Human Interaction |
Primary outcome
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.
2 secondary outcomes
Change in Pain Intensity Score (Numeric Rating Scale (NRS))
Time frame: Baseline to 1.5 day
Change in Score for Fatigue, Anxiety, and Depression
Time frame: Baseline to 1.5 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arya B Mohabbat principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog Interaction and Human Interaction in people with Fibromyalgia, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score (time frame: Baseline to 1.5 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.