Clinical trial NCT00512590: Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
Official title: Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain
Functional Status
Self-Efficacy
Distress
Keywords: fibromyalgia
relaxation
imagery
pain
functional status
self efficacy
minority health
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
name: American Nurses Foundation
First posted: 2007-08-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain as measured by Short-Form McGill Pain Questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Functional Status as measured by the Fibromyalgia Impact Questionnaire
timeFrame: 10 weeks
measure: Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
timeFrame: 10 weeks
measure: Distress as measured by the 17-item Mental Health Inventory
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Victoria Menzies, PhD, APRN-BC
role: PRINCIPAL_INVESTIGATOR
References: