Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Pelvic Pain
- Sponsor
- Universidad de Granada
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Perceived health-related quality of life
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Marie Carmen Valenza
PhD
Universidad de Granada
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of chronic pelvic pain with at least 6 months of evolution
Exclusion Criteria
- •Active urogenital infection
- •Pregnancy
- •A surgical intervention involving lumbo-pelvic region over the past year
Outcomes
Primary Outcomes
Perceived health-related quality of life
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- 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)