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

Not Applicable

Completed

• Conditions: Fibromyalgia; Pain; Functional Status; Self-Efficacy; Distress
• Interventions: Behavioral: Relaxation and Guided Imagery

• Registration Number: NCT00512590
• Lead Sponsor: Florida International University

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-04
• Study Completion: 2006-06
• Status Verified: 2007-08
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Last Update Submitted: 2007-08-03
• Study First Posted: 2007-08-07
• Last Update Posted: 2007-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Relaxation and Guided Imagery	-

Primary Outcome Measures

Name	Time	Method
Pain as measured by Short-Form McGill Pain Questionnaire	10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States