Graded Exposure Therapy in Women With Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fear-avoidance behaviors
研究概览
简要总结
Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. The objective of this study was to evaluate the effects of graded exposure therapy in women with chronic pelvic pain.
详细描述
Chronic pelvic pain (CPP) is considered as nonmalignant recurrent or continuous pain related to the structures of the pelvis. This condition lasts at least 6 months, and many times is associated with negative cognitive, emotional, sexual and behavioral consequences.In addition to the high economic cost, CPP is also costly in emotional and psychological suffering. This clinical trial aims to evaluate the effects of a program based on graded exposure therapy in women with chronic pelvic pain.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic pelvic pain
- •Moderate fear of movement
排除标准
- •Other clinical diagnosis.
- •Other pathology such as neurological disease.
- •Cognitive impairment.
研究组 & 干预措施
Graded exposure therapy
Patients in this group received graded exposure therapy added to physiotherapy
干预措施: Graded exposure therapy (Other)
Physiotherapy
Patients included in this group received the standard treatment based on a physiotherapy approach.
干预措施: Physiotherapy (Other)
Control group
Waiting list patients
结局指标
主要结局
Fear-avoidance behaviors
时间窗: Baseline, 6 weeks
Changes from baseline to the end of the intervention will be assessed with the Fear Avoidance Beliefs Questionnaire (FABQ) using the physical activity subscale. This subscale focus on patients' beliefs about how physical activity affected their pain. The values ranges from 0 to 24 with higher scores indicating higher levels of fear-avoidance beliefs.
次要结局
- Pain assessed by the Brief Pain Inventory(Baseline, 6 weeks)
- Disability(Baseline, 6 weeks)
- Activity performance(Baseline, 6 weeks)
研究者
Marie Carmen Valenza
Principal investigator
Universidad de Granada