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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512590
First Posted: August 7, 2007
Last Update Posted: August 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sigma Theta Tau International (Nursing Honor Society)
American Nurses Foundation
Information provided by:
Florida International University
  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
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

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Pain as measured by Short-Form McGill Pain Questionnaire [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512590


Locations
United States, Florida
Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
Sigma Theta Tau International (Nursing Honor Society)
American Nurses Foundation
Investigators
Principal Investigator: Victoria Menzies, PhD, APRN-BC Florida International University
  More Information

ClinicalTrials.gov Identifier: NCT00512590     History of Changes
Other Study ID Numbers: Menzies-1
First Submitted: August 3, 2007
First Posted: August 7, 2007
Last Update Posted: August 7, 2007
Last Verified: August 2007

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