Chronic Pelvic Pain in Endometriosis

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863663
• Other study ID #: 9534-PTE2023
• Status: Recruiting
• Start date: January 28, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University of Pecs
• Contact: Zsófia Kovács-Szabó, BSc
• Phone: +36204317662
• Email: kovacs-szabo.zsofia[@]pte.hu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• questionnaire
cross sectional questionnaire

Locations

Country	Name	City	State
Hungary	University of Pécs	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic pain	Visual Analogue Scale - 1-10 points; The more the points the severe the pain.	1 day
Primary	Pain self-efficacy	Pain self-efficacy questionnaire points Scale:0-60 Max points:60 Minimum points:0 The higher the point the better the condition is.	1 day
Primary	Physical activity	Global Physical Activity Questionnaire, min/week MET/week	1 day
Primary	Pelvic pain impact	Pelvic Pain Impact Questionnaire, Max points: 40 Minimum points: 0 Scale: higher points indicate higher impact on every day life	1 day
Primary	health-related quality of life	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.	1 day
Primary	perceived stress	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	1 day
Secondary	Level of pain catastrophizing	Pain Catastrophizing Scale 13 questions ranging from 0-4 Minimum points: 0 Maximum points: 52 Higher points indicate higher level of pain catastrophizing	1 day
Secondary	body mass index	BMI kg/m2	1 day
Secondary	level of education	what is your educational level? 4 types of answer; unfinished elementary school; finished elementary school; high school; bachelor/masters degree	1 day
Secondary	Endometriosis and menstrual pain	Endopain 4D Questionnaire; The ENDOPAIN-4D comprises 21 items divided into four subparts: spontaneous pelvic pain and dysmenorrhoea (questions 1 to 10), dyspareunia (questions 11 to 13), intestinal pain symptoms (questions 14 to 16), and other symptoms (questions 17 to 21). Each question is first scored dichotomously as yes/no.	1 day
Secondary	lifestyle factors	Questions about alcohol intake, smoking, nutritional habits; Open ended questions.	1 day