Self-management Program in Chronic Pelvic Pain
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|ClinicalTrials.gov Identifier: NCT03617627|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pelvic Pain||Behavioral: Self-management intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||October 21, 2018|
|Estimated Study Completion Date :||October 29, 2018|
Experimental: Experimental group
Patients will be included in a self-management intervention.
Behavioral: Self-management intervention
Self-management intervention will include presentation and discussion of various topics regarding chronic pain mechanisms and pain self-monitoring. The intervention will also incorporate a task-oriented approach focused on relevant activities in order to acquire coping skills.
No Intervention: Control group
Patients will receive a booklet with information.
- 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)
- Change in performance of activities [ Time Frame: Change from baseline self-perceived performance at 7 weeks ]Canadian Occupational Performance Measure will be used to evaluate changes in patient's self-perception over time including performance and satisfaction scored from 0 to 10. Higher values represented improvement on perceived performance and satisfaction
- Change in activity levels [ Time Frame: Change from baseline self-reported activity levels at 7 weeks ]Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.
- Change in anxiety levels. [ Time Frame: Change from baseline anxious symptoms at 7 weeks ]Anxiety will be evaluated using the Beck Anxiety Inventory. It contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
- Change in depressive symptoms [ Time Frame: Change from baseline depressive symptoms at 7 weeks ]Depression will be evaluated using the Beck Depression Inventory. It contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate severe depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617627
|Contact: Marie Carmen Valenza, firstname.lastname@example.org|
|Department of Physical Therapy||Recruiting|
|Granada, Spain, 18071|
|Contact: Marie Carmen Valenza, MsC email@example.com|
|Principal Investigator:||Marie Carmen Valenza, phD||Universidad de Granada|