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Completed

NCT Number: NCT05863663

Chronic Pelvic Pain in Endometriosis

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.

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Key information

Conditions

Endometriosis Behavior Chronic Pain Chronic Pelvic Pain Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Physical Inactivity Quality of Life Sedentary Behavior Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Pécs

Pécs, 7621, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

cross sectional questionnaire

Primary outcomes

  1. Pelvic pain

    Time frame: 1 day

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

  2. 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.

  3. Physical activity

    Time frame: 1 day

    Global Physical Activity Questionnaire, min/week MET/week

  4. 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

  5. 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.

  6. 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

Secondary outcomes

  1. Level of pain catastrophizing

    Time frame: 1 day

    Pain Catastrophizing Scale 13 questions ranging from 0-4 Minimum points: 0 Maximum points: 52 Higher points indicate higher level of pain catastrophizing

  2. body mass index

    Time frame: 1 day

    BMI kg/m2

  3. level of education

    Time frame: 1 day

    what is your educational level? 4 types of answer

    • unfinished elementary school
    • finished elementary school
    • high school
    • bachelor/masters degree

  4. Endometriosis and menstrual pain

    Time frame: 1 day

    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.

  5. lifestyle factors

    Time frame: 1 day

    Questions about alcohol intake, smoking, nutritional habits

    Open ended questions.

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 18, 2023
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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