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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00512590
Enrollment
14
Registered
2007-08-07
Start date
2005-04-30
Completion date
2006-06-30
Last updated
2007-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distress, Fibromyalgia, Functional Status, Pain, Self-Efficacy

Keywords

fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health

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.

Interventions

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.

Sponsors

Sigma Theta Tau International Honor Society of Nursing
CollaboratorOTHER
American Nurses Foundation
CollaboratorOTHER
Florida International University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pain as measured by Short-Form McGill Pain Questionnaire10 weeks

Secondary

MeasureTime frame
Functional Status as measured by the Fibromyalgia Impact Questionnaire10 weeks
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM10 weeks
Distress as measured by the 17-item Mental Health Inventory10 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026