Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
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Purpose
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 | Intervention |
|---|---|
|
Fibromyalgia Pain Functional Status Self-Efficacy Distress |
Behavioral: Relaxation and Guided Imagery |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia |
- Pain as measured by Short-Form McGill Pain Questionnaire [ Time Frame: 10 weeks ]
- 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 ]
| Enrollment: | 14 |
| Study Start Date: | April 2005 |
| Study Completion Date: | June 2006 |
| Arms | Assigned Interventions |
|---|---|
| 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. |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Florida | |
| Florida International University | |
| Miami, Florida, United States, 33199 | |
| Principal Investigator: | Victoria Menzies, PhD, APRN-BC | Florida International University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00512590 History of Changes |
| Other Study ID Numbers: | Menzies-1 |
| Study First Received: | August 3, 2007 |
| Last Updated: | August 3, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Florida International University:
|
fibromyalgia relaxation imagery pain |
functional status self efficacy minority health |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013