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

August 3, 2007 updated by: Florida International University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33199
        • Florida International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain as measured by Short-Form McGill Pain Questionnaire
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional Status as measured by the Fibromyalgia Impact Questionnaire
Time Frame: 10 weeks
10 weeks
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
Time Frame: 10 weeks
10 weeks
Distress as measured by the 17-item Mental Health Inventory
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Collaborators

American Nurses Foundation
Sigma Theta Tau International Honor Society of Nursing

Investigators

  • Principal Investigator: Victoria Menzies, PhD, APRN-BC, Florida International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2007

Last Update Submitted That Met QC Criteria

August 3, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Menzies-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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