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

This study has been completed.

Sponsor:

Collaborator:

Sigma Theta Tau International (Nursing Honor Society)

Information provided by:

Florida International University

ClinicalTrials.gov Identifier:

NCT00512590

First received: August 3, 2007

Last updated: NA

Last verified: August 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 3, 2007

Last Updated Date

August 3, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Fibromyalgia
Pain
Functional Status
Self-Efficacy
Distress

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Experimental

Intervention: Behavioral: Relaxation and Guided Imagery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00512590

Other Study ID Numbers ^ICMJE

Menzies-1

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Florida International University

Collaborators ^ICMJE

Sigma Theta Tau International (Nursing Honor Society)

Investigators ^ICMJE

Principal Investigator:

Victoria Menzies, PhD, APRN-BC

Florida International University

Information Provided By

Florida International University

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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