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Clinical Trials/NCT05863663
NCT05863663
Completed
Not Applicable

Examination of Chronic Pelvic Pain in Women With Endometriosis in the Context of the Degree of Physical Activity and Quality of Life

University of Pecs1 site in 1 country262 target enrollmentJanuary 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
University of Pecs
Enrollment
262
Locations
1
Primary Endpoint
Pelvic pain
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2023
End Date
December 1, 2023
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Pelvic pain

Time Frame: 1 day

Visual Analogue Scale - 1-10 points; The more the points the severe the pain.

health-related quality of life

Time Frame: 1 day

Short-Form 36 Questionnaire Subscales: physical functioning, role functioning/physical, role functioning/emotional, energy fatigue, emotional well-being, social functioning, pain, general health, health change Scoring is different between the items.

perceived stress

Time Frame: 1 day

Perceived Stress Scale Scale: 0-40 Minimum points: 0 Maximum points:40 Scoring: Higher scores indicate high perceived stress Scores ranging from 0-13 are considered low perceived stress, ranging from 14-26 are considered moderate stress and ranging from 27-40 are considered high perceived stress

Pelvic pain impact

Time Frame: 1 day

Pelvic Pain Impact Questionnaire, Max points: 40 Minimum points: 0 Scale: higher points indicate higher impact on every day life

Pain self-efficacy

Time Frame: 1 day

Pain self-efficacy questionnaire points Scale:0-60 Max points:60 Minimum points:0 The higher the point the better the condition is.

Physical activity

Time Frame: 1 day

Global Physical Activity Questionnaire, min/week MET/week

Secondary Outcomes

  • level of education(1 day)
  • body mass index(1 day)
  • Level of pain catastrophizing(1 day)
  • lifestyle factors(1 day)
  • Endometriosis and menstrual pain(1 day)

Study Sites (1)

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