FibromyalgiaNCT00512590
Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia
A study testing Relaxation and Guided Imagery in people with Fibromyalgia and Pain, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Pain, Functional Status
- What is being tested?
- Relaxation and Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia
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.
Read the 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.
- Conditions
- Fibromyalgia, Pain, Functional Status, Self-Efficacy, Distress
- Being tested
- Relaxation and Guided Imagery
- Keywords
- fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and Guided ImageryBehavioural
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 group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: Relaxation and Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by Short-Form McGill Pain Questionnaire
Measured: 10 weeks
Secondary outcomes (3)
Functional Status as measured by the Fibromyalgia Impact Questionnaire
Measured: 10 weeks
Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM
Measured: 10 weeks
Distress as measured by the 17-item Mental Health Inventory
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startApr 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, American Nurses Foundation
- Investigators
- Victoria Menzies, PhD, APRN-BC, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512590
- Sponsor's protocol ID
- Menzies-1
- Status last verified
- Aug 2007
- First submitted
- 3 Aug 2007
- Last updated
- 7 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00512590
- Acronym / sponsor ID
- Menzies-1
- Conditions
- Fibromyalgia, Pain, Functional Status, Self-Efficacy, Distress
- Keywords
- fibromyalgia, relaxation, imagery, pain, functional status, self efficacy, minority health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, American Nurses Foundation
- Study start
- Apr 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Relaxation and Guided Imagery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation and Guided ImageryThe 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. | Behavioural | Experimental |
Primary outcome
Pain as measured by Short-Form McGill Pain Questionnaire
Time frame: 10 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Menzies, PhD, APRN-BC principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and Guided Imagery in people with Fibromyalgia and Pain, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured by Short-Form McGill Pain Questionnaire (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2007.