Chronic Pelvic Pain in Endometriosis

Sponsor
University of Pecs (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863663
Collaborator
(none)
300
1
10.1
29.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Examination of Chronic Pelvic Pain in Women With Endometriosis in the Context of the Degree of Physical Activity and Quality of Life
Actual Study Start Date :
Jan 28, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
endometriosis

Women diagnosed with endometriosis between 18-50 years old

Other: questionnaire
cross sectional questionnaire

healthy women without endometriosis

Women without the diagnosis of endometriosis between 18-50 years old

Other: questionnaire
cross sectional questionnaire

Outcome Measures

Primary Outcome Measures

  1. Pelvic pain [1 day]

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

  2. Pain self-efficacy [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 [1 day]

    Global Physical Activity Questionnaire, min/week MET/week

  4. Pelvic pain impact [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 [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 [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 Outcome Measures

  1. Level of pain catastrophizing [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 [1 day]

    BMI kg/m2

  3. level of education [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 [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 [1 day]

    Questions about alcohol intake, smoking, nutritional habits Open ended questions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pécs Pécs Hungary 7621

Sponsors and Collaborators

  • University of Pecs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pecs
ClinicalTrials.gov Identifier:
NCT05863663
Other Study ID Numbers:
  • 9534-PTE2023
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pecs
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023