Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this pilot study was to test the effects of a 10-week relaxation and guided imagery intervention on pain perception, functional status, self-efficacy and levels of distress in Hispanic adults diagnosed with fibromyalgia.

Detailed Description
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Fibromyalgia (FM), a chronic widespread pain condition with an unknown pathogenesis and no known cure, affects 2 to 4 million persons in the adult US population. One of the most common conditions seen in rheumatology clinics world wide, including the US, Mexico, and Spain, FM is accompanied by various co-occurring symptoms such as fatigue, disturbed sleep, stiffness and depression. While studies of fibromyalgia in Hispanics have been reported in Spain, Brazil and Argentina, very few such studies have been reported in the United States. This gap exists despite data indicating that there are a reported 16 million Hispanics with rheumatic diseases in the US and that Hispanics (self-identified) form the fastest growing minority group in this country.

Official Title
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Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia

Conditions
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Fibromyalgia, Pain, Functional Status, Self-Efficacy, Distress

Intervention / Treatment
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* Behavioral: Relaxation and Guided Imagery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 18 and older diagnosis of fibromyalgia based on the American College of Rheumatology criteria and documented by the patient's primary physician a minimum of a 6th grade education level an ability to understand and sign the consent form and understand and complete the intervention (pencil and paper) assignments. Exclusion Criteria: presence of other systemic rheumatologic conditions such as rheumatoid arthritis, lupus, and/or Sjogren's Disease adequate functional status as indicated by a Fibromyalgia Impact Questionnaire score < 20 inadequate cognitive status as evidenced by a Mini-Mental State Exam score < 25 history of epilepsy major communicative disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Behavioral: Relaxation and Guided Imagery<br>* The intervention consisted of 3 relaxation and guided imagery audiotapes used in a proscribed order for 6 weeks and used in any order for weeks 7 through 10. Protocol: Tape 1: Basic Relaxation used for weeks 1 and 2. Tape 2: Pleasant Scene Imagery to elicit sensory involvement for enhanced sense of overall well-being; used for weeks 3 and 4. Tape 3: End-State Imagery designed to facilitate improved symptom management; used for weeks 5 and 6. Any of the tapes used as often as desired but at least once daily for weeks 7 to 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by Short-Form McGill Pain Questionnaire |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status as measured by the Fibromyalgia Impact Questionnaire |  | 10 weeks | 
| Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM |  | 10 weeks | 
| Distress as measured by the 17-item Mental Health Inventory |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health