Psychological Pain Treatment in Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis; Pelvic Pain; Chronic Pain
• Interventions: Other: Mindfulness-based psychological treatment; Other: Non-specific psychological treatment

• 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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based treatment	Mindfulness-based psychological treatment	The mindfulness-based psychological treatment consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT) and Acceptance and commitment therapy (ACT). The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: 1. mindfulness-training (including meditation and yoga), 2. therapy based on ACT, and 3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.
Non-specific treatment	Non-specific psychological treatment	The non-specific general psychological treatment is matched the mindfulness-based psychological treatment and consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Client-centered therapy. The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: 1. relaxation and physical training, 2. therapy based on the non-specific factors of psychological treatment which emphasize a focus on the relation and alliance between the therapist and the client and the therapist being a warm empathic, non-directive and unconditionally accepting support, and 3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.

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)

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

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

North Denmark Regional Hospital; 🇩🇰 Hjørring, Denmark