The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Unprovoked pain change, post-intervention
研究概览
简要总结
Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study
排除标准
- •inability to read and understand Swedish
- •severe mental illness
- •currently in treatment for vulvodynia
结局指标
主要结局
Unprovoked pain change, post-intervention
时间窗: Baseline to post-intervention (6 weeks)
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)
Unprovoked pain change, one year post-treatment
时间窗: 1 year after end of clinical treatment
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.
Provoked pain change, post-intervention
时间窗: post-intervention (6 weeks)
Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and post-intervention (6 weeks)
Unprovoked pain change, end of clinical treatment
时间窗: Baseline to end of clinical treatment (typically 10-12 months) or 1 year following inclusion
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and after completion of clinical treatment or 1 year following inclusion.
Provoked pain change, end of clinical treatment
时间窗: after clinical treatment (typically 10-12 months) or 1 year following inclusion
Change in self-reported provoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and after completion of clinical treatment or 1 year following inclusion.
Provoked pain change, one year post-treatment
时间窗: 1 year after ending of clinical treatment
Change in self-reported unprovoked pain assessment, assessed by Visual Analogue Scale (VAS), between baseline and 1 year after completion of clinical treatment.
次要结局
- Satisfaction with Life change(Baseline to post-intervention (6 weeks))
- Sexuality(Baseline to post-intervention (6 weeks))
- Cost-effectiveness, assessed with the EQ-5D scale(Baseline to one year after completion of clinical treatment)
- Sexual function parameters(Baseline to end of clinical treatment)
- Number of visits for clinical treatment(One year after the end of clinical treatment)
- Number of days off work(Baseline to end of clinical treatment)
- Satisfaction with Life change, one year post-treatment(Baseline to one year post-treatment)