The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change of measure of Q tip test assessing pain intensity
研究概览
简要总结
The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.
详细描述
Provoked vestibulodynia (PVD) is the term describing a syndrome of provoked, localized allodynia of the vestibule of the vulva, not explained by another condition, and lasting more than 3 months. PVD is not a defined disease but rather a symptom. It is thought that PVD represent a group of distinct disorders that have been classified together because they produce pain in the same anatomic location.
Studies found that different factors such as genetic, inflammation, recurrent vaginitis, allergy, trauma, emotional and neural may be involved in the development of PVD.
Treatment of PVD is generally predicated on a trial and error basis, because the pathogenesis is not defined. The result is that many forms of therapeutic interventions have been used, yet the evidence remains largely inconclusive, the response rates varies considerably, and many women do not respond to any of the treatments. It is therefore important to recognize which factors mediate the syndrome's severity, and influence the effectiveness of treatments.
The proposed study will evaluate how different patients' characteristics (personality, cognitive) and responses (emotional and behavioral) influence the natural history of the syndrome and the response to treatment. The study is based on the bio-psycho-social model and the adult attachment theory, which integrates psychosocial factors to define susceptibility to acquire pain disorders and predict response to therapy. According to this model, choosing effective coping strategy during a crisis and receiving support from a spouse are vital for recovery.
The study aim to:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
- •On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
- •No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.
排除标准
- •other causes for vulvar pain
- •pregnancy or a planned pregnancy in the upcoming year
- •diagnosis of chronic disease that may affect central nervous system or general function.
- •usage of psychiatric medications or those affecting pain modulation.
- •unprovoked or mixed vulvodynia
研究组 & 干预措施
Hypertonic pelvic muscle dysfunction
In this subgroup, pelvic floor (PF) muscles become tight and tender. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule.
干预措施: Pelvic floor physical therapy (Procedure)
Hormonally mediated PVD
The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. The entire vestibule is tender and vestibular mucosa is often dry and thin.
干预措施: estriol cream (ovestin) (Drug)
Neuroproliferative PVD
In this condition, we speculate that women have an increased number of nociceptors in the vestibular mucosa. Pain is primary and there is tenderness of the entire vestibule.
干预措施: Low-level-laser therapy (Procedure)
结局指标
主要结局
Change of measure of Q tip test assessing pain intensity
时间窗: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months
The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.
次要结局
- Measurement of vestibular tenderness using a vulvar algesiometer(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.)
- Change of pain using Visual analog scale(Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months)
- Adherence to therapy(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.)
- Female sexual function index questionnaire(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.)
- Pelvic floor hypertonicity measurements(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.)
- Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms)(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.)
研究者
Ahinoam Lev-Sagie
MD
Meir Medical Center