Clinical trial NCT05863663: Chronic Pelvic Pain in Endometriosis
Official title: Examination of Chronic Pelvic Pain in Women With Endometriosis in the Context of the Degree of Physical Activity and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Physical Inactivity
Chronic Pelvic Pain Syndrome
Quality of Life
Keywords: endometriosis
pelvic pain
physical activity
chronic pain
health related quality of life
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18-50 years old and diagnosed with endometriosis.

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.

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

Primary outcomes:
measure: Pelvic pain
timeFrame: 1 day
measure: Pain self-efficacy
timeFrame: 1 day
measure: Physical activity
timeFrame: 1 day
measure: Pelvic pain impact
timeFrame: 1 day
measure: health-related quality of life
timeFrame: 1 day
measure: perceived stress
timeFrame: 1 day
Secondary outcomes:
measure: Level of pain catastrophizing
timeFrame: 1 day
measure: body mass index
timeFrame: 1 day
measure: level of education
timeFrame: 1 day
measure: Endometriosis and menstrual pain
timeFrame: 1 day
measure: lifestyle factors
timeFrame: 1 day
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
Study officials:
References: