Self-management Program in Chronic Pelvic Pain

NCT03617627 | Completed

• 1 other identifier: DF00800UG
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Pain

Keywords

chronic pain; women; self-management

Outcome Measures

Primary Outcomes (2)

• Perceived health-related quality of life

  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 from baseline health-related quality of life at 7 weeks

• Change in coping strategies

  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 from baseline coping strategies at 7 weeks

Secondary Outcomes (4)

• Change in performance of activities

  Change from baseline self-perceived performance at 7 weeks

• Change in activity levels

  Change from baseline self-reported activity levels at 7 weeks

• Change in anxiety levels.

  Change from baseline anxious symptoms at 7 weeks

• Change in depressive symptoms

  Change from baseline depressive symptoms at 7 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients will be included in a self-management intervention.

Behavioral: Self-management intervention

Control group

NO INTERVENTION

Patients will receive a booklet with information.

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Carmen Valenza, phD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: July 23, 2018
• Primary Completion: October 21, 2018
• Study Completion: April 29, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

ES (1)