Lichen Sclerosus - the Influence on Quality of Life
- Conditions
- Lichen Sclerosus
- Interventions
- Other: Standard care and sexological counseling
- Registration Number
- NCT03419377
- Lead Sponsor
- Vendsyssel Hospital
- Brief Summary
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
- Detailed Description
The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 158
- Patients diagnosed with Lichen Sclerosus
- Age over 18 years
- Patients who does not understand or speak Danish
- Patients with a psychiatric diagnosis and can not follow the course
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care and sexological counseling Standard care and sexological counseling Standard care including gynecological examination and 6-8 sexological consultations.
- Primary Outcome Measures
Name Time Method Quality of Life in women with Lichen Sclerosus Six months Change in EuroQol five dimension (EQ-5D) score. The descriptive system comprises 5 dimensions (mobili-ty, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vendsyssel Hospital
🇩🇰Hjørring, Denmark