Trial document





This trial has been registered retrospectively.
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  DRKS00014362

Trial Description

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Title

Partnership, experience of pain and psychological stress in endometriosis

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Trial Acronym

[---]*

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/Gynaekologische-Psychologie.139867.0.html

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Brief Summary in Lay Language

Endometriosis is a common, gynecological, inflammatory disorder defined by the presence of benign but metastatic endometrial tissue implants outside of the uterus. Endometriosis is often associated with severe dysmenorrhea, pelvic pain, pain during sexual intercourse, and infertility. Aim of this study is to explore the relationship between partnership, experience of pain and stress in 120 women with and without endometriosis and their partners.

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Brief Summary in Scientific Language

The prevalence of pelvic endometriosis is about 10-15% in the general population, whereas it approaches about 70% in women treated in fertility clinics. There is currently no cure for endometriosis and successful treatment of endometriosis-associated symptoms typically requires medical as well as surgical interventions. With the prognosis of endometriosis being indefinate, this can be an additional stress factor for affected patients and their partners. Endometriosis presents itself with diverse symptoms of varying severity, which can considerable limit the quality of life of affected women.
Aim of this study is to explore the relationship between partnership, pain and stress in women with and without endometriosis and their partners. Furthermore, the impact of variables such as sexuality, wish for a child, social support, depression, anxiety and spirituality in relation to endometriosis will be investigated.
The study is planned as a quantitative cross-sectional study with a total sample size of N = 120 women and their partners. All patients undergoing laparoscopy for organic findings during their treatment at the Department of Gynecological Endocrinology and Fertility Disorders at the University Hospital Heidelberg can take part in the study. Psychometric parameters are recorded via questionnaires.

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Organizational Data

  •   DRKS00014362
  •   2018/03/29
  •   [---]*
  •   yes
  •   Approved
  •   S-301/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N80 -  Endometriosis
  •   N97 -  Female infertility
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Interventions/Observational Groups

  •   Investigation of women with endometriosis and wish for a child (E+C+) plus their partners after laparoscopy at Heidelberg University Hospital or Innsbruck University Hospital. The questionnaire comprises items to partnership, experience of pain, psychological stress, sexuality, wish for a child, social support, anxiety, depression and spirituality.
  •   Investigation of women with endometriosis and no wish for a child (E+C-) plus their partners after laparoscopy at Heidelberg University Hospital or Innsbruck University Hospital. The questionnaire comprises items to partnership, experience of pain, psychological stress, sexuality, wish for a child, social support, anxiety, depression and spirituality.
  •   Investigation of women with no endometriosis and wish for a child (E-C+) plus their partners after laparoscopy at Heidelberg University Hospital or Innsbruck University Hospital. The questionnaire comprises items to partnership, experience of pain, psychological stress, sexuality, wish for a child, social support, anxiety, depression and spirituality.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

One-time questionaire investigation on partnership, experience of pain and stress in women affected by endometriosis and their Partners after laparoscopy at University Hospital Heidelberg or University Hospital Innsbruck. The questionnaire was put composed from the following questionnaires: Endometriosis Health Profile (EHP-5), Deutscher Schmerzfragebogen (German Pain Questionnaire, DSF), Perceived Stress Scale (PSS), Depression Anxiety Stress Scales (DASS), Questions from Swiss Household Panel (SHP), Screen-IVF, Female Sexual Function Index (FSF) and Spiritual and Religious Attitudes in Dealing with Illness (SpREUK)

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/30
  •   240
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

All women aged 18 to 45 years (plus their partners) undergoing laparoscopy for organic findings during their treatment at the Department of Gynecological Endocrinology and Fertility Disorders at the University Hospital Heidelberg / at University Hospital Innsbruck can take part in the study.

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Exclusion Criteria

Exclusion criteria are refusal of participation and/or insufficient knowledge of german language as well as presence of life-threatening diseases.

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Addresses

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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Ms.  Prof. Dr.  Beate  Ditzen 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Universitätsklinik für GynäkologischeEndokrinologie undReproduktionsmedizin, Department Frauenheilkunde
    • Ms.  Prof. Dr.  Bettina  Toth 
    • Anichstraße 35
    • 6020  Innsbruck
    • Austria
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Ms.  M.Sc. Psych.  Maren  Schick 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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    • Institut für Medizinische Psychologie, Universitätsklinikum Heidelberg
    • Ms.  M.Sc. Psych.  Maren  Schick 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische PsychologieZentrum für Psychosoziale Medizin (ZPM)UniversitätsKlinikum Heidelberg
    • Ms.  Prof. Dr.  Beate  Ditzen 
    • Bergheimer Str. 20
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.