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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863663
Other study ID # 9534-PTE2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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