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Study with endometriosis patients and their partners: helpful aspects, wishes and post-traumatic growth in coping with this disease

Organizational Data

DRKS-ID:
DRKS00031775
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-05-04
Last update in DRKS:
2023-06-12
Registration type:
Prospective

Acronym/abbreviation of the study

EndoGrowth

URL of the study

https://www.klinikum.uni-heidelberg.de/zentrum-fuer-psychosoziale-medizin-zpm/institut-fuer-medizinische-psychologie/forschung/gynaekologische-und-peripartale-psychologie/forschung

Brief summary in lay language

This study is aimed at endometriosis patients and their partners, who are recruited through various endometriosis centres in Germany. The aim is to gain a personal insight into the experience of dealing with the disease. For this purpose, the test persons fill out a questionnaire and are interviewed in a one-hour video-interview. The questionnaire examines post-traumatic growth (the experience of positive changes after a traumatic experience). In addition, the wishes and needs of the affected persons and their partners are examined, as well as the supportive aspects of their everyday life that help them to cope better with the illness.

Brief summary in scientific language

Endometriosis is a chronic disease in which uterus-like tissue is found outside the uterus and affects approximately 10% of women of childbearing age. For a long time, this condition remained a taboo. However, in recent years, endometriosis has come more into the focus of society and research. Numerous studies have also investigated the negative impact on the quality of life and psychological well-being of those affected. Despite all of this, there are still research deficits in this area. Few studies address whether positive aspects emerge in processing this condition. It is still unclear, what supportive and helpful aspects sufferers experience that help them cope with their condition. In addition, the concept of posttraumatic growth – experiencing positive changes as a result of processing a traumatic event – is increasingly in the spotlight of chronic illnesses, as posttraumatic growth has been noted in numerous sufferers of these disorders. However, there is still no knowledge as to whether this is true in endometriosis, even if some sources suggest post-traumatic growth in this disease, which is why it is essential to verify it. We also know that partnership plays an important role in the management of illnesses and especially chronic diseases. Since these also have psychosocial consequences on partners of affected persons, it is important to examine these as well.

Health condition or problem studied

Free text:
endometriosis sufferers and their healthy partners
ICD10:
N80 - Endometriosis
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Observation group: The target size of the study is 60 subjects (30 endometriosis patients and 30 partners). A clinical survey will be conducted using a standardized questionnaire (German version of the PTGI - posttraumatic growth inventory) and semi-standardized interviews. These participants will be recruited through different endometriosis centres in Germany (Evaluation in Heidelberg only).

Endpoints

Primary outcome:
One of the main aims of the study is to find out whether and which positive changes (in the sense of post-traumatic growth) the affected persons and their partners experience in dealing with their illness. It is also important to find out which aspects of the participants' everyday lives are helpful and supportive in dealing with the disease. For this purpose, interviews are conducted with endometriosis patients and their partners (regardless of the time of diagnosis).
Secondary outcome:
Furthermore, the aim of the study is to identify the wishes and needs of all participants in order to make it easier for them to deal with the disease endometriosis.

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Institut für Medizinische Psychologie Heidelberg

Recruitment period and number of participants

Planned study start date:
2023-06-15
Actual study start date:
No Entry
Planned study completion date:
2023-09-30
Actual Study Completion Date:
No Entry
Target Sample Size:
60
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Age of majority, ability to give consent with signed informed consent form, sufficient knowledge of the German language. In the case of affected persons, the diagnosis must be clinically established. If the partner refuses to participate, the patient can also participate as an individual. Conversely, this also applies to the partner.

Exclusion Criteria

underage, unable to give consent, poor knowledge of the German language, self-reported mental risk factors (mental instability, acute psychiatric illness), refusal to participate in the study.

Addresses

Primary Sponsor

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49 6221 568137
Fax:
+49 6221 565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49 6221 568137
Fax:
+49 6221 565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Contact for Public Queries

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49 6221 568137
Fax:
+49 6221 565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Principal Investigator

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Prof. Dr. Tewes Wischmann
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
+49 6221 568137
Fax:
+49 6221 565303
Contact per E-Mail
URL:
http://www.medpsych.uni-hd.de/

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
No Entry
Contact per E-Mail
URL:
http://www.medizinische-fakultaet-hd.uni-heidelberg.de/einrichtungen/zentrale-einrichtungen/ethikkommission

Vote of leading Ethics Committee

Date of ethics committee application:
2023-02-25
Ethics committee number:
S-115/2023
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-04-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
Anfang 2024
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry