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

Florida International University14 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia Pain Functional Status Self-Efficacy Distress

Interventions

Relaxation and Guided ImageryBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Florida International University

Miami, Florida, United States

Outcomes

Primary Outcomes

Pain as measured by Short-Form McGill Pain Questionnaire

Time frame: 10 weeks

Secondary Outcomes

Functional Status as measured by the Fibromyalgia Impact Questionnaire

Time frame: 10 weeks

Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM

Time frame: 10 weeks

Distress as measured by the 17-item Mental Health Inventory

Time frame: 10 weeks

Data from ClinicalTrials.gov

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