A randomised controlled trial of light therapy in the treatment of premenstrual syndrome (PMS)

ISRCTN ISRCTN80834259
DOI https://doi.org/10.1186/ISRCTN80834259
Secondary identifying numbers N0158108034
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedUrological and Genital Diseases: Premenstrual syndrome (PMS)
InterventionWomen 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 typeOther
Primary outcome measureReduction in the overall score for PMS symptomatology
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaWomen 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 criteriaNot provided at time of registration
Date of first enrolment01/06/2002
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Obstetrics and Gynaecology Academic Department
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

North Staffordshire Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan