Lichen Sclerosus - the Influence on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Quality of Life in women with Lichen Sclerosus
研究概览
简要总结
A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Lichen Sclerosus
- •Age over 18 years
排除标准
- •Patients who does not understand or speak Danish
- •Patients with a psychiatric diagnosis and can not follow the course
结局指标
主要结局
Quality of Life in women with Lichen Sclerosus
时间窗: 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.
次要结局
未报告次要终点
研究者
Dorte Melgaard Kristiansen
Research Coordinator
Vendsyssel Hospital