Young Vulvodynia: Effect and Efficacy of a Multimodal Treatment for Young Women With Vulvar Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Genital Pain Intensity
研究概览
简要总结
The aim of this SCED-study is to evaluate a multimodal treatment for vulvodynia in young women. The main questions it aims to answer are:
Is multimodal treatment effective for provoked vulvodynia in young women? How is multimodal treatment experienced by young women with vulvodynia?
Participants will respond to frequent questionnaires (two times a week) during a baseline period of 4,5 or 6 weeks, as well as during their treatment period ( a total of 25 weeks). In addition they will respond to pre-, post-treatment and 6 month follow-up questionnaires.
详细描述
The current study is an effectiveness evaluation, applying a sequential single case experimental AB design (SCED) with randomized baseline length, implemented at a youth guidance center. Potential participants will be informed about the study and answer a few questions digitally to ensure that participation in the study is appropriate for them. An assessment will then be conducted and questions will be asked about the pain, psychological, sexual and relational health, and a diagnostic interview will be conducted to exclude other psychological issues that needs to be prioritized before vulvodynia treatment.
After the assessment interview and inclusion, participants will be randomized in tiers to a 4, 5, or 6 week baseline period. Thereafter, the treatment will begin. During the baseline and treatment period, participants will complete a short self-assessment questionnaire, twice a week, to measure pain (primary outcome) and other key variables. To facilitate the repeated assessments, we will use the m-Path app, which was developed by KU Leuven University in Belgium to easily evaluate treatment for both patients and therapists. In addition to the repeated assessments, the treatment will be evaluated through a comprehensive web-based self-assessment questionnaire before and after the intervention and at a six-month follow-up. The outcome measures are in line with Core Outcome set in Vulvodynia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to baseline length allocations.
入排标准
- 年龄范围
- 15 Years 至 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biological sex female
- •15-23 years of age
- •Diagnosed with Provoked vulvodynia
排除标准
- •Severe psychological issues that should be prioritized before vulvodynia treatment (e.g., substance abuse, psychosis)
- •Ongoing pregnancy
- •Childbirth within the last year
- •Post-traumatic stress disorder (PTSD) related to sexual trauma
- •Insufficient mastery of the Swedish language
- •No experience of vaginal sex, as vaginismus might be suspected, which requires different treatment
研究组 & 干预措施
Baseline period
During a 4, 5 or 6 week waiting period, participants respond to a short questionnaire twice a week.
Multimodal Treatment
Multimodal Treatment.
干预措施: Multimodal treatment (Behavioral)
结局指标
主要结局
Genital Pain Intensity
时间窗: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.
Provoked pain during sexual and non-sexual activities. Seven activities where pain is rated on a scale from 0 to 10. Higher scoring indicates higher degree of pain. There are also subsequent questions regarding whether they have performed the described activity or not within a specific time frame.
次要结局
- Pelvic Floor Tension(Pre, post treatment (25 weeks after the baseline measurement started) and at a 6 month follow-up. During baseline and treatment period measured twice a week, for 25 weeks.)
- Sexual Satisfaction(Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up)
- Change in quality of life(Pre and post treatment, and at 6 months follow-up)
- Sexual Function(FSFI: Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. FSFI-6 Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.)
- Participant Identified Treatment Goal(Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up. Repeated measures twice a week during baseline (4, 5 or 6 weeks) and treatment period, for 25 weeks.)
- Sexual Pain Coping(Pre, post treatment (25 weeks after the baseline measurement started) and at 6 month follow-up, during baseline (4, 5 or 6 weeks) and treatment period measured twice a week for 25 weeks´.)
- Pain Catastrophizing(Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up)
- Depressive symptoms(Pre and post treatment, and at 6 months follow-up)
- Anxiety symptoms(Pre- and post treatment and at 6 month follow-up.)
- Change in life interference, sexual function interference and communication.(Pre and post treatment (25 weeks after the baseline measurement started) and at 6 months follow-up)
研究者
Rebecca Lennartsson
Doctoral Student
Region Örebro County