The primary objective is to gain insight into the effects of guided imagery on pain intensity in people with fibromyalgia. Secondary objective is to gain insight into the effects on self efficacy and functional status.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is pain intensity.
Secondary outcome
Secundary outcomes are self efficacy and functional status.
Background summary
The cause of fibromyalgia is unknown, and no specific medical treatment exists.
Therefore it is important that people with fibromyalgia learn to manage their
complaints by themselves.
It is expected that the use of guided imagery techniques provides an
opportunity for self management of complaints. Guided imagery is a relaxation
intervention, in which the care provider guides the patient in visualising a
pleasant, relaxing situation (e.g. walking in a forest, lying on the beach).
The care provider asks the patient about his sensory impressions (e.g.
temperature, noises), and by doing so the patient's ability to visualise the
pleasant situation can be improved, and the intended purpose (e.g. pain
reduction) may be reached.
There is already a lot of evidence regarding the effectiveness of guided
imagery on for instance pain and well-being in oncological patients (see the
meta-review van Luebbert et al., 2001).
About the effects of guided imagery in people with fibromyalgia less is known.
So far there are only a few studies published in this area (Fors en Götestam,
2000; Fors et al., 2002; Menzies et al., 2006; Menzies en Kim, 2008). These
four studies provide insufficient evidence, particularly because the results
are not in all regards unequivocal. Therefore, more research is needed on the
effects of guided imagery in this specific patient group. The proposed project
will provide more insight into the effectiveness of guided imagery with regard
to pain intensity, self efficacy and functional status of people with
fibromyalgia.
Study objective
The primary objective is to gain insight into the effects of guided imagery on
pain intensity in people with fibromyalgia. Secondary objective is to gain
insight into the effects on self efficacy and functional status.
Study design
This study has a randomised pretest posttest control group design. The
experimental condition consists of 2 group meetings supervised by a specialised
reumatology nurse in combination with instruction and use of guided imagery.
In the control condition patients also have 2 group meetings, but they are not
instructed about guided imagery.
Intervention
The experimental condition consists of group support (2 meetings) in
combination with instruction about and use of guided imagery techniques.
Participants in the experimental condition receive a CD with guided imagery
exercises and they are requested to use these exercises at a daily base at
home.
In the control condition there are two group meetings as well, but no
instruction on guided imagery is provided.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness (if applicable):
The burden for patients is very limited and concerns:
* participation in 2 group meetings of 1,5 hrs each, guided by a specialised
rheumatology nurse
* filling in a set of questionnaires about pain, self efficacy and functional
status at 3 measurement points, which will take about 0,5 hrs/measurement
* writing a pain diary during 4 weeks (between group meeting 1 and 2), which
will take 5 minutes/day.
Participation involves no risks for the patients. The lack of risks, the
limited research burden and the expected benefits of the intervention, justify
the research.
Postbus 1568
3500 BN Utrecht
NL
Postbus 1568
3500 BN Utrecht
NL
Listed location countries
Age
Inclusion criteria
- having a diagnosis of fibromyalgia for less than 6 years, proved by a (copy of a) diagnosis by a reumatologist based on the classification criteria of the American College of Rheumatology
- being able to travel to the group meetings in Utrecht
- being able to sit down for about 1,5 hrs, during the groups meetings
- sufficient hearing abilities for hearing the exercises
Exclusion criteria
- having a psychiatric disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL28451.041.09 |
| OMON | NL-OMON23507 |