|- candidate number||6898|
|- NTR Number||NTR2172|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2010|
|- Secondary IDs||NL28451.041.09 METC UMC Utrecht|
|- Public Title||Guided imagery in patients with fibromyalgia.|
|- Scientific Title||Use of guided imagery in patients diagnosed with fibromyalgia: effects on pain, self-efficacy and functional status.|
|- hypothesis||Guided imagery will have positive effects on pain, self-efficacy and functional status of patients diagnosed with fibromyalgia.|
|- Healt Condition(s) or Problem(s) studied||Fibromyalgia|
|- Inclusion criteria||1. 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 criteria||A comorbid psychiatric disorder.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-nov-2009|
|- planned closingdate||31-dec-2010|
|- Target number of participants||70|
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.
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 outcome||Daily pain (VAS).|
|- Secondary outcome||1. Self-efficacy (Chronic Pain Self-Efficacy Scale);|
2. Functional status (Fibromyalgia Impact Questionnaire).
|- Timepoints||1. 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD Renate Verkalk|
|- CONTACT for SCIENTIFIC QUERIES||PhD Renate Verkalk|
|- Sponsor/Initiator ||Fonds NutsOhra|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objectives: |
To investigate the effects of a 4-week intervention of guided imagery on pain level, functional status, and self-efficacy in persons with fibromyalgia.
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.
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.
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)|
|- RECORD||19-jan-2010 - 9-feb-2010|