Self-management Program in Chronic Pelvic Pain

NCT ID: NCT03617627

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-04-29

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.

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Patients will be included in a self-management intervention.

Group Type: EXPERIMENTAL

Self-management intervention

Intervention Type: 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.

Control group

Patients will receive a booklet with information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Marie Carmen Valenza

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Carmen Valenza, phD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Department of Physical Therapy

Granada, , Spain

Countries

Spain

Other Identifiers

DF00800UG

Identifier Type: -

Identifier Source: org_study_id