Back to resultsPilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
Primary Purpose
Fibromyalgia, Pain, Functional Status
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation and Guided Imagery
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health
Eligibility 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.
Sites / Locations
- Florida International University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
Pain as measured by Short-Form McGill Pain Questionnaire
Secondary Outcome Measures
Functional Status as measured by the Fibromyalgia Impact Questionnaire
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
Distress as measured by the 17-item Mental Health Inventory
Full Information
NCT ID
NCT00512590
First Posted
August 3, 2007
Last Updated
August 3, 2007
Sponsor
Florida International University
Collaborators
Sigma Theta Tau International Honor Society of Nursing, American Nurses Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00512590
Brief Title
Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
Official Title
Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Florida International University
Collaborators
Sigma Theta Tau International Honor Society of Nursing, American Nurses Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Pain, Functional Status, Self-Efficacy, Distress
Keywords
fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Relaxation and Guided Imagery
Intervention Description
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 Outcome Measure Information:
Title
Pain as measured by Short-Form McGill Pain Questionnaire
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Functional Status as measured by the Fibromyalgia Impact Questionnaire
Time Frame
10 weeks
Title
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
Time Frame
10 weeks
Title
Distress as measured by the 17-item Mental Health Inventory
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Menzies, PhD, APRN-BC
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
12. IPD Sharing Statement
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Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
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