A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Rate of adverse events
研究概览
简要总结
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
- •Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
- •Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
排除标准
- •Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- •Post-menopausal state
- •Actual or past pregnancy in the last year
- •Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
- •Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses surgery)
- •Prior use of laser treatments for vulvar pain
- •Expected changes of medication that could influence pain perception (e.g. analgesic, antidepressant)
- •Other medical conditions that could interfere with the study
结局指标
主要结局
Rate of adverse events
时间窗: 2-week post-treatment evaluation
To document any adverse events.
Recruitment rate
时间窗: Baseline to 2-week post-treatment evaluation
To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
Completion and dropout rates
时间窗: 2-week post-treatment evaluation
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
Adherence rate
时间窗: 2-week post-treatment evaluation
To determine acceptability by assessing adherence to treatment sessions
Willingness to recommend the treatment
时间窗: 2-week post-treatment evaluation
To determine acceptability by assessing whether the participant would recommend the treatment.
Blinding effectiveness
时间窗: 2-week post-treatment evaluation
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists. Evaluated by asking the question: ''What treatment do you think you have received / given? ''
Level of satisfaction with the treatment
时间窗: 2-week post-treatment evaluation
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
Completeness of data
时间窗: Baseline to 2-week post-treatment evaluation
To examine the percentage of completed outcome measures.
次要结局
- Change in sexual distress(Baseline to 2-week post-treatment evaluation)
- Change in vulvar pain sensitivity(Baseline to 2-week post-treatment evaluation)
- Change in vulvar blood circulation(Baseline to 2-week post-treatment evaluation)
- Change in sexual function(Baseline to 2-week post-treatment evaluation)
- Patient's global impression of change(Baseline to 2-week post-treatment evaluation)
- Change in pain catastrophization(Baseline to 2-week post-treatment evaluation)
- Change in pain intensity during intercourse(Baseline to 2-week post-treatment evaluation)
- Change in pain quality(Baseline to 2-week post-treatment evaluation)
- Change in fear of pain(Baseline to 2-week post-treatment evaluation)
研究者
Mélanie Morin
Researcher and Associate Professor
Université de Sherbrooke