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

Sponsor

Florida International University (Other)

Overall Status

Completed

CT.gov ID

NCT00512590

Collaborator

Sigma Theta Tau International Honor Society of Nursing (Other), American Nurses Foundation (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Pain Functional Status Self-Efficacy Distress	Behavioral: Relaxation and Guided Imagery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental	Behavioral: Relaxation and Guided Imagery 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.

Arm

Intervention/Treatment

Experimental: Experimental

Behavioral: Relaxation and Guided Imagery

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.

Outcome Measures

Primary Outcome Measures

Pain as measured by Short-Form McGill Pain Questionnaire [10 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.