A randomised controlled trial of light therapy in the treatment of premenstrual syndrome (PMS)
| ISRCTN | ISRCTN80834259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80834259 |
| Protocol serial number | N0158108034 |
| Sponsor | Department of Health (UK) |
| Funder | North Staffordshire Research and Development Consortium (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital 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
Dr PMS O'Brien
Scientific
Scientific
Obstetrics and Gynaecology Academic Department
Maternity Block
City General
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 554998 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the efficacy of light therapy in the treatment of PMS. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Premenstrual syndrome (PMS) |
| Intervention | Women will be recruited from PMS clinics, GP surgeries and through the media. They will record symptoms daily for two cycles. A structured clinical interview for DSM IV personality disorders (SCID) will be carried out 1 month single blind, to exclude placebo responders. Randomised to either actual or placebo light masks. They will continue to keep a daily diary. |
| Intervention type | Other |
| Primary outcome measure(s) |
Reduction in the overall score for PMS symptomatology |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Key inclusion criteria | Women between 18 and 45 years of age with regular menstrual cycles who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for premenstrual dysphoric disorder (PMDD). They need to be able to write and read English. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Obstetrics and Gynaecology Academic Department
Stoke-on-Trent
ST4 6QG
United Kingdom
ST4 6QG
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 |
