Psychological Pain Treatment in Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis; Pelvic Pain; Chronic Pain

• Registration Number: NCT02761382
• Lead Sponsor: University of Aarhus

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Status Verified: 2018-06
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic pain measured on Numeric Rating Scale	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 Outcome Measures

Name	Time	Method
Pain acceptance measured by Chronic Pain Acceptance Questionnaire	Change from pre-intervention to post-intervention (12 weeks)	Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Work Ability measured by the Work Ability Index	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
Endometriosis related symptoms measured on Numeric Rating Scale	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.
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)	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.
Quality of life measured by the Endometriosis Health Profile 30 questionnaire	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

Trial Locations

Locations (3)

Aarhus University Hospital, Department of Obstetrics and Gynecology; 🇩🇰 Aarhus N, Denmark

Copenhagen University Hospital, Department of Gynaecology; 🇩🇰 Copenhagen, Denmark

North Denmark Regional Hospital; 🇩🇰 Hjørring, Denmark