Chronic Pelvic Pain in Endometriosis

NCT ID: NCT05863663

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 262 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-28
• Study Completion Date: 2023-12-01

Brief Summary

Endometriosis is a chronic, inflammatory disease affecting 10% (1 out of 10) of women of reproductive age. Pelvic pain is common among women with endometriosis.

Women with chronic pelvic pain conditions have elevated rates of relational stress and lower quality of life.

The aim of our study is to analyse the extent of pelvic pain associated with endometriosis, as well as the study focuses on correlations between pelvic pain and physical activity, pain-related self-efficacy, perceived stress and different aspects of health related quality of life.

Detailed Description

A cross-sectional study was conducted involving women with diagnosis of endometriosis.Patients with endometriosis and healthy women as controls are also recruited in the study.

The investigators used self-composed questionnaire for evaluating socio-demographic data and life-style factors, gynecological anamnesis, endometriosis diagnosis and further chronic conditions. Pain intensity was evaluated using Visual Analog Scale (VAS) focusing on perceived pain at present, the avarage perceived pain last month and the most intense perceived pain last month. Further measuring instruments were the Perceived Stress Scale (PSS) for evaluating stress levels among subjects, SF 36 short form health survey questionnaire for measuring health-related quality of life, Global Physical Activity Questionnaire (GPAQ) for evaluating physical activity of the subjects, Pain Catastrophizing Scale (PCS) for examining the subjects' perception of and reaction for a painful event, Pelvic Pain Impact Questionnaire (PPIQ) for evaluating the pelvic pain impact on the subjects' ability to perform physical activity, prolonged sitting, limitations in social activities, sexual activities and intimacy, Pain Self-Efficacy Questionnaire (PSEQ) for evaluating the confidence in performing different activities.

The participants are women between 18-50 years old and provided written informed consent. The investigators used convenience sampling method and the data were collected through online surveys. Data were analysed using IBM SPSS 28.0 and Microsoft Excel 2018 softwares and descriptive statistics, average, mean, standard deviation, two sample t-test, Pearson chi square test, Kolmogorov-Smirnov and Shapiro-Wilk test.

Dependent variables were the level of pelvic pain, physical activity, scores on the questionnairies, body mass index (BMI), independent variables were age, diagnosis of endometriosis, educational level.

In the course of this study, the cultural adaptation of the PSEQ questionnaire into Hungarian is also carried out based on Beaton's guidelines.

Conditions

Endometriosis; Physical Inactivity; Chronic Pelvic Pain Syndrome; Quality of Life

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

endometriosis

Women diagnosed with endometriosis between 18-50 years old

questionnaire

Intervention Type: OTHER

cross sectional questionnaire

Interventions

questionnaire

cross sectional questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• women
• for study population: women diagnosed with endometriosis
• for control: women not diagnosed with endometriosis
• women between 18-50 years old
• signed informed consent

Exclusion Criteria

• malignant tumor
• current pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pécs

Pécs, , Hungary

Countries

Hungary

References

Kovacs-Szabo Z, Acs P, Makai A, Hock M. Validity and reliability testing of the Pelvic Pain Impact Questionnaire. Sci Rep. 2025 Oct 3;15(1):34628. doi: 10.1038/s41598-025-18269-3.

Reference Type: DERIVED

PMID: 41044332 (View on PubMed)

Other Identifiers

9534-PTE2023

Identifier Type: -

Identifier Source: org_study_id