Sleep intervention in patients with fibromyalgia
| ISRCTN | ISRCTN87743899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87743899 |
| Protocol serial number | N0388179219 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Hillingdon Hospital NHS Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 31/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Alice Theadom
Scientific
Scientific
The Hillingdon Hospital NHS Trust
Pield Health Road
Uxbridge
UB8 3NN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To explore whether a sleep intervention tailored to people's individual needs can improve sleep quality and quality of life in patients with fibromyalgia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Fibromyalgia |
| Intervention | Current practice vs current practice and psychological intervention. 2 groups: a treatment group and an intervention group. 31/08/2012: Please note that this trial was abandoned before starting due to a lack of funding. |
| Intervention type | Other |
| Primary outcome measure(s) |
To improve sleep quality and quality of life of patients with fibromyalgia syndrome. |
| Key secondary outcome measure(s) |
Increased understanding of the association between sleep, pain and fatigue |
| Completion date | 01/01/2009 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with fibromyalgia. |
| Key exclusion criteria | 1. Sleep disorder 2. Change in medical treatment in the last 3 months 3. No experience of sleep difficulties |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Hillingdon Hospital NHS Trust
Uxbridge
UB8 3NN
United Kingdom
UB8 3NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
