Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Perceived health-related quality of life
研究概览
简要总结
Chronic pelvic pain is a serious health condition with an estimated prevalence of 15% women worldwide.Treatment is a challenge given the different pain generators described. It is important to develop self-management interventions to reduce the frustration associated with its management.
详细描述
Chronic pelvic pain is defined as non-cyclic pain lasting for 6 or more months, that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks and is of sufficient severity to cause functional disability or lead to medical care. It can occur continuously or intermittently, with intensity severe enough to limit activities of daily living. It is frequent in women. The primary aim of this study isto evaluate the efficacy of a self-management intervention, as compared with an educational booklet in improving health-related quality of life and coping strategies, occupational performance, activity level and psycho-emotional symptoms 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic pelvic pain with at least 6 months of evolution
排除标准
- •Active urogenital infection
- •Pregnancy
- •A surgical intervention involving lumbo-pelvic region over the past year
研究组 & 干预措施
Experimental group
Patients will be included in a self-management intervention.
干预措施: Self-management intervention (Behavioral)
Control group
Patients will receive a booklet with information.
结局指标
主要结局
Perceived health-related quality of life
时间窗: Change from baseline health-related quality of life at 7 weeks
Health-related quality of life will be assessed using the EuroQol-5D. This scale consists of a descriptive system and the EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, oain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Higher scores indicate more problems. In the visual analogue scale the patient rate the pain from 100 (best imaginable health state) to 0 (worst imaginable health state). Higher values represent a better health state.
Change in coping strategies
时间窗: Change from baseline coping strategies at 7 weeks
Coping strategies will be evaluated using the Coping Strategies Questionnaire (CSQ). It assesses eight different coping strategies for pain which describe two types of coping: adaptive coping (diverting Attention, coping self-statements, ignoring sensations, reinterpreting pain sensation, hoping and cognitive distracting) and maladaptive coping (catastrophizing, and faithing and praying). Participants score each item using a 7-point scale to indicate how often they use that strategy to manage their pain (0 never, 3 sometimes, and 6 always)
次要结局
- Change in activity levels(Change from baseline self-reported activity levels at 7 weeks)
- Change in depressive symptoms(Change from baseline depressive symptoms at 7 weeks)
- Change in anxiety levels.(Change from baseline anxious symptoms at 7 weeks)
- Change in performance of activities(Change from baseline self-perceived performance at 7 weeks)
研究者
Marie Carmen Valenza
PhD
Universidad de Granada