Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03042728|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Dog Interaction Behavioral: Human Interaction||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||September 7, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Dog interaction
Dog interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Dog Interaction
A therapy dog will visit the patients.
Active Comparator: Human Interaction
Human interaction will be received by patients in addition to usual care of fibromyalgia.
Behavioral: Human Interaction
A human will visit the patients.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042728
|Contact: Stephanie Clark, PhD||507-284-9039||Clark.Stephanie1@mayo.edu|
|Contact: Heather Ondler Hinson||507-284-4799||OndlerHinson.Heather@mayo.edu|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55901|
|Contact: Arya B Mohabbat, MD 507-284-9039 firstname.lastname@example.org|
|Contact: Saswati Mahapatra, MS 507-284-5404 email@example.com|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Arya B Mohabbat||Mayo Clinic|