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

Florida International University (FIU)

Status: Completed

Conditions: Fibromyalgia; Distress; Functional Status; Self-Efficacy; Pain

Treatments: Behavioral: Relaxation and Guided Imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT00512590

Menzies-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Experimental

Experimental group

Treatment:

Behavioral: Relaxation and Guided Imagery