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NCT Number: NCT02761382

Psychological Pain Treatment in Endometriosis

This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).

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Key information

Conditions

Endometriosis Chronic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Department of Obstetrics and Gynecology, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endometriosis diagnosed by laparoscopy or MRI.
  • Moderate to severe endometriosis-related chronic pelvic pain.
  • Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.

Exclusion criteria

  • Fibromyalgia, Colitis Chron or Colitis Ulcerosa
  • Severe psychiatric diagnosis
  • Pregnancy or planned pregnancy during the study period

Treatment and study plan

Mindfulness-based psychological treatment

Other

Non-specific psychological treatment

Other

Primary outcomes

  1. Pelvic pain measured on Numeric Rating Scale

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.

Secondary outcomes

  1. Quality of life measured by the Endometriosis Health Profile 30 questionnaire

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Quality of life will be measured by the Endometriosis Health Profile 30 questionnaire (EHP-30) which is a patient generated questionnaire that measure endometriosis-related quality of life

  2. Endometriosis related symptoms measured on Numeric Rating Scale

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Dyspareunia, Dysmenorrhea, Dyschezia, Dysuria, Tiredness, Constipation, Diarrhea, Nausea and Vomiting will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a weekly diary.

  3. Pain acceptance measured by Chronic Pain Acceptance Questionnaire

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Pain acceptance measured by Chronic Pain Acceptance Questionnaire

  4. Work Ability measured by the Work Ability Index

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Work ability will be measured by the Work Ability Index (WAI) which is a questionnaire used to measure changes in work ability due to a specific intervention

  5. Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.

Other outcomes

  1. Psychological flexibility measured by the Acceptance and Action Questionnaire-II

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II)

  2. Mindfulness measured by the Five Facet Mindfulness Questionnaire

    Time frame: Change from pre-intervention to post-intervention (12 weeks)

    Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Copenhagen University Hospital, Denmark
  • Endometriose Foreningen
  • TrygFonden, Denmark

Registry information

Official study title

Mindfulness-based Psychological Pain Treatment in Endometriosis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2016
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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