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Self-management Program in Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03617627
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 4, 2018
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

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.

Condition or disease Intervention/treatment Phase
Chronic Pelvic Pain Behavioral: Self-management intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of chronic pelvic pain with at least 6 months of evolution

Exclusion Criteria:

  • Active urogenital infection
  • Pregnancy
  • Cancer
  • Dementia
  • A surgical intervention involving lumbo-pelvic region over the past year

Information from the National Library of Medicine

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 identifier (NCT number): NCT03617627

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Contact: Marie Carmen Valenza, phd 958249863

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Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, MsC   
Sponsors and Collaborators
Universidad de Granada
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Principal Investigator: Marie Carmen Valenza, phD Universidad de Granada

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Responsible Party: Marie Carmen Valenza, PhD, Universidad de Granada Identifier: NCT03617627     History of Changes
Other Study ID Numbers: DF00800UG
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Carmen Valenza, Universidad de Granada:
chronic pain

Additional relevant MeSH terms:
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Pelvic Pain
Neurologic Manifestations
Signs and Symptoms