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

NCT ID: NCT00512590

Last Updated: 2007-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Pain Functional Status Self-Efficacy Distress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

Relaxation and Guided Imagery

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sigma Theta Tau International Honor Society of Nursing

OTHER

Sponsor Role collaborator

American Nurses Foundation

OTHER

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Principal Investigators

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Victoria Menzies, PhD, APRN-BC

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

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Florida International University

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Menzies-1

Identifier Type: -

Identifier Source: org_study_id