Self-management Program in Chronic Pelvic Pain

Sponsor
Universidad de Granada (Other)
Overall Status
Completed
CT.gov ID
NCT03617627
Collaborator
(none)
44
1
2
9.2
4.8

Study Details

Study Description

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
  • Behavioral: Self-management intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 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 :
Jul 23, 2018
Actual Primary Completion Date :
Oct 21, 2018
Actual Study Completion Date :
Apr 29, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Perceived health-related quality of life [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 [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 [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 [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. [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Therapy Granada Spain 18071

Sponsors and Collaborators

  • Universidad de Granada

Investigators

  • Principal Investigator: Marie Carmen Valenza, phD, Universidad de Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie Carmen Valenza, PhD, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT03617627
Other Study ID Numbers:
  • DF00800UG
First Posted:
Aug 6, 2018
Last Update Posted:
Mar 4, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie Carmen Valenza, PhD, Universidad de Granada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2020