NCT05863663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

April 12, 2023

Last Update Submit

July 11, 2024

Conditions

Keywords

endometriosispelvic painphysical activitychronic painhealth related quality of life

Outcome Measures

Primary Outcomes (6)

  • Pelvic pain

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

    1 day

  • 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

  • Physical activity

    Global Physical Activity Questionnaire, min/week MET/week

    1 day

  • 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

  • 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

  • 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 Outcomes (5)

  • Level of pain catastrophizing

    1 day

  • body mass index

    1 day

  • level of education

    1 day

  • Endometriosis and menstrual pain

    1 day

  • lifestyle factors

    1 day

Study Arms (1)

endometriosis

Women diagnosed with endometriosis between 18-50 years old

Other: questionnaire

Interventions

cross sectional questionnaire

endometriosis

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women between 18-50 years old and diagnosed with endometriosis.

You may qualify if:

  • women
  • for study population: women diagnosed with endometriosis
  • for control: women not diagnosed with endometriosis
  • women between 18-50 years old
  • signed informed consent

You may not qualify if:

  • malignant tumor
  • current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, 7621, Hungary

Location

Related Publications (1)

  • Kovacs-Szabo Z, Acs P, Makai A, Hock M. Validity and reliability testing of the Pelvic Pain Impact Questionnaire. Sci Rep. 2025 Oct 3;15(1):34628. doi: 10.1038/s41598-025-18269-3.

MeSH Terms

Conditions

EndometriosisSedentary BehaviorPelvic PainMotor ActivityChronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 18, 2023

Study Start

January 28, 2023

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations