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Guided imagery in patients with fibromyalgia.


- candidate number6898
- NTR NumberNTR2172
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2010
- Secondary IDsNL28451.041.09 METC UMC Utrecht
- Public TitleGuided imagery in patients with fibromyalgia.
- Scientific TitleUse of guided imagery in patients diagnosed with fibromyalgia: effects on pain, self-efficacy and functional status.
- ACRONYM
- hypothesisGuided imagery will have positive effects on pain, self-efficacy and functional status of patients diagnosed with fibromyalgia.
- Healt Condition(s) or Problem(s) studiedFibromyalgia
- Inclusion criteria1. Diagnosed fibromyalgia (American College of Rheumatology: Wolfe et al., 1990);
2. Being able to travel;
3. Being able to sit 1,5 hours;
4. Sufficient hearing.
- Exclusion criteriaA comorbid psychiatric disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-nov-2009
- planned closingdate31-dec-2010
- Target number of participants70
- InterventionsEXPERIMENTAL
1. Two 1,5 hour group sessions: group conversation, instruction about Guided Imagery (GI), distribution of cd with GI exercises;
2. 1 or 2 GI exercises per day during 4 weeks.

CONTROL
Two 1,5 hour group sessions: group conversation.

Guided Imagery has been defined as a dynamic, psychophysiologic process in which a person is guided to imagine, and experience, an internal reality in the absence of external stimuli. A person who uses imagery may experience an affective, behavioural or physiologic (i.e., psychophysiologic) response without a real stimulus event. In this way mental imagery may be used to alter one's physiologic process, mental state, self-image, performance, or behavior.
- Primary outcomeDaily pain (VAS).
- Secondary outcome1. Self-efficacy (Chronic Pain Self-Efficacy Scale);
2. Functional status (Fibromyalgia Impact Questionnaire).
- Timepoints1. Pain: daily during 4 weeks;
2. Self-efficacy and functional status:
A. Pre-intervention (pre-test);
B. After 4 weeks (post-test);
C. After 10 weeks (follow-up).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD Renate Verkalk
- CONTACT for SCIENTIFIC QUERIESPhD Renate Verkalk
- Sponsor/Initiator Fonds NutsOhra
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryObjectives:
To investigate the effects of a 4-week intervention of guided imagery on pain level, functional status, and self-efficacy in persons with fibromyalgia.

Design:
Longitudinal, prospective, randomized controlled clinical trial.

Setting and subjects:
The sample includes people diagnosed with fibromyalgia ≤6 years (American College of Rheumatology) who are able to travel, sit 1,5 hours and have sufficient hearing.

Intervention:
Participants randomized to Guided Imagery (GI) receive two 1,5 hour group sessions, including: group conversation, a set of four guided imagery exercises on cd and instructions how to use at least one exercise daily for 4 weeks. Participants randomized to the control groups receive two 1,5 hour group sessions with group conversation.

Measures:
All participants complete daily pain VAS-scales. The Chronic Pain Self-Efficacy Scale and the Fibromyalgia Impact Questionnaire are completed at baseline, 4, and 10 weeks.
- Main changes (audit trail)
- RECORD19-jan-2010 - 9-feb-2010


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