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Completed

NCT Number: NCT00512590

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University

Miami, Florida, 33199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxation and Guided Imagery

Behavioral

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.

Primary outcomes

  1. Pain as measured by Short-Form McGill Pain Questionnaire

    Time frame: 10 weeks

Secondary outcomes

  1. Functional Status as measured by the Fibromyalgia Impact Questionnaire

    Time frame: 10 weeks

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

    Time frame: 10 weeks

  3. Distress as measured by the 17-item Mental Health Inventory

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • American Nurses Foundation
  • Sigma Theta Tau International Honor Society of Nursing

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Aug 7, 2007
Registry last updated
Aug 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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