Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
This study examines feasibility of R&D activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.
详细描述
Provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young women. It represents the most common cause of pain during sexual intercourse. Existing treatment approaches are predominantly based on clinical experience, observational studies, or reports of expert committees. Although, physiotherapy is one of the most commonly recommended treatments, high quality randomized controlled trials are needed to assess its effectiveness.
This is a phase I, feasibility study with the purpose of testing R&D activities for a planned full size RCT. Additionally, patients experiences with the somatocognitive therapy intervention, assessment measures and condition itself will be collected using qualitative interviews. The results will be applied to adjust time-line of the treatment, outcome measures and therapeutic approach before commencing full scale RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed provoked vestibulodynia diagnosis
排除标准
- •vulvar pain is not clearly linked to intercourse or pressure applied to vestibule or usage of tampon
- •active infection or dermatologic lesion in the vulvar region
结局指标
主要结局
Recruitment rate
时间窗: 5 months
Number of eligible patients and number of recruited participants per week
Evaluation of Tampon test as a primary outcome measure - qualitative interviews
时间窗: 8 months
All participants are asked in individual qualitative interviews if they experience a Tampon test as a relevant instrument for assessing pain sensitivity experienced during intercourse.
Adherence
时间窗: 8 months
Adherence is defined as the number of participants who fully complete the battery of self-report questionnaires, 14-day diary, biweekly forms about the received treatment and perform Tampon tests.
Follow-up rate
时间窗: 8 months
The follow-up rate is measured by the percentage of participants who were followed up successfully until the 8 months follow-up
Evaluation of Tampon test as a primary outcome measure - score variance
时间窗: 8 months
Participants perform Tampon test 3 times in course of 14 days (day1, 7 and 14) at each of the 3 time points (baseline, post-treatment, 8 months after baseline), 9 scores in total. Numerical rating scale (0-10) will be used to score pain intensity. Intra-individual score variance will be estimated as difference between the min and max score at each time point for every participant. Lower variability is better.
Adverse events
时间窗: 8 months
If participant is pulled out of the study because somatocognitive therapy is deemed as a non-appropriate treatment (e.g. participant is instead referred to psychological counselling), such event is recorded as adverse.
次要结局
- Implementation and acceptability of the somatocogntive therapy intervention(8 months)
- Evaluation of somatocognitive therapy intervention's potential to reduce pain catastrophizing(8 months)
- Evaluation of somatocognitive therapy intervention's potential to reduce pain(8 months)
- Evaluation of somatocognitive therapy intervention's potential to improve sexual functioning(8 months)
- Evaluation of somatocognitive therapy intervention's potential to reduce psychological distress(8 months)