Skip to main content
OpenTrials
Completed

NCT Number: NCT03617627

Self-management Program in Chronic Pelvic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pelvic Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management Intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.