EndometriosisNCT05863663
Chronic Pelvic Pain in Endometriosis
An observational study of Endometriosis and Physical Inactivity, run by University of Pecs at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Physical Inactivity, Chronic Pelvic Pain Syndrome
- What is being tested?
- questionnaire
- How many people
- 262 participants
- Where
- 1 siteHungary
- Study dates
- 28 Jan 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between 18-50 years old and diagnosed with endometriosis.
Who may be able to join
- women
- for study population: women diagnosed with endometriosis
- for control: women not diagnosed with endometriosis
- women between 18-50 years old
- signed informed consent
Who cannot join
- malignant tumor
- current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Chronic Pelvic Pain in Women With Endometriosis in the Context of the Degree of Physical Activity and Quality of Life
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.
Read the 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.
In the course of this study, the cultural adaptation of the PSEQ questionnaire into Hungarian is also carried out based on Beaton's guidelines.
- Being tested
- questionnaire
- Keywords
- endometriosis, pelvic pain, physical activity, chronic pain, health related quality of life
- Medical subject headings
- Endometriosis, Sedentary Behavior, Pelvic Pain, Motor Activity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
cross sectional questionnaire
| Study group | Role | What they receive |
|---|---|---|
| endometriosis | Women diagnosed with endometriosis between 18-50 years old Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain
Visual Analogue Scale - 1-10 points; The more the points the severe the pain.
Measured: 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.
Measured: 1 day
Physical activity
Global Physical Activity Questionnaire, min/week MET/week
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 day
Secondary outcomes (5)
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
Measured: 1 day
body mass index
BMI kg/m2
Measured: 1 day
level of education
what is your educational level? 4 types of answer
- unfinished elementary school
- finished elementary school
- high school
- bachelor/masters degree
Measured: 1 day
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.
Measured: 1 day
lifestyle factors
Questions about alcohol intake, smoking, nutritional habits
Open ended questions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start28 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863663
- Sponsor's protocol ID
- 9534-PTE2023
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41044332
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Chronic Pelvic Pain in Women With Endometriosis in the Context of the Degree of Physical Activity and Quality of Life
- ClinicalTrials.gov ID
- NCT05863663
- Acronym / sponsor ID
- 9534-PTE2023
- Keywords
- endometriosis, pelvic pain, physical activity, chronic pain, health related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
In the course of this study, the cultural adaptation of the PSEQ questionnaire into Hungarian is also carried out based on Beaton's guidelines.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometriosis | – | Other: questionnaireWomen diagnosed with endometriosis between 18-50 years old |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between 18-50 years old and diagnosed with endometriosis.
Key inclusion criteria (5 listed)
- women
- for study population: women diagnosed with endometriosis
- for control: women not diagnosed with endometriosis
- women between 18-50 years old
- signed informed consent
Key exclusion criteria (2 listed)
- malignant tumor
- current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairecross sectional questionnaire | Other | endometriosis |
Primary outcome
Pelvic pain
Time frame: 1 day
Visual Analogue Scale - 1-10 points; The more the points the severe the pain.
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.
Physical activity
Time frame: 1 day
Global Physical Activity Questionnaire, min/week MET/week
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
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.
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
5 secondary outcomes
Level of pain catastrophizing
Time frame: 1 day
body mass index
Time frame: 1 day
level of education
Time frame: 1 day
Endometriosis and menstrual pain
Time frame: 1 day
lifestyle factors
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 41044332Kovacs-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Physical Inactivity, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.