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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 3, 2007
CompletedFirst Posted
Study publicly available on registry
August 7, 2007
CompletedAugust 7, 2007
August 1, 2007
August 3, 2007
August 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain as measured by Short-Form McGill Pain Questionnaire
10 weeks
Secondary Outcomes (3)
Functional Status as measured by the Fibromyalgia Impact Questionnaire
10 weeks
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
10 weeks
Distress as measured by the 17-item Mental Health Inventory
10 weeks
Study Arms (1)
Experimental
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida International Universitylead
- Sigma Theta Tau International Honor Society of Nursingcollaborator
- American Nurses Foundationcollaborator
Study Sites (1)
Florida International University
Miami, Florida, 33199, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Menzies, PhD, APRN-BC
Florida International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2007
First Posted
August 7, 2007
Study Start
April 1, 2005
Study Completion
June 1, 2006
Last Updated
August 7, 2007
Record last verified: 2007-08