Psychological Pain Treatment in Endometriosis

Mindfulness-based 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).

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Endometriosis; Pelvic Pain
• Intervention / Treatment: Other: Mindfulness-based psychological treatment; Other: Non-specific psychological treatment

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital, Department of Obstetrics and Gynecology
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital, Department of Gynaecology
  • Hjørring, Denmark
    • North Denmark Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based 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: mindfulness-training (including meditation and yoga),; therapy based on ACT, and; patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.	Other: Mindfulness-based psychological treatment
Experimental: Non-specific 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: relaxation and physical training,; 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; patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain.	Other: Non-specific psychological treatment
No Intervention: Waiting list control; Participants in this arm will be on the waiting list to participate in one of the two experimental treatments after a period of six months. Participants will receive medical treatment as usual in this period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic pain measured on Numeric Rating Scale	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.	Change from pre-intervention to post-intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by the Endometriosis Health Profile 30 questionnaire	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	Change from pre-intervention to post-intervention (12 weeks)
Endometriosis related symptoms measured on Numeric Rating Scale	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.	Change from pre-intervention to post-intervention (12 weeks)
Pain acceptance measured by Chronic Pain Acceptance Questionnaire	Pain acceptance measured by Chronic Pain Acceptance Questionnaire	Change from pre-intervention to post-intervention (12 weeks)
Work Ability measured by the Work Ability Index	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	Change from pre-intervention to post-intervention (12 weeks)
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)	Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.	Change from pre-intervention to post-intervention (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological flexibility measured by the Acceptance and Action Questionnaire-II	Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II)	Change from pre-intervention to post-intervention (12 weeks)
Mindfulness measured by the Five Facet Mindfulness Questionnaire	Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ)	Change from pre-intervention to post-intervention (12 weeks)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; TrygFonden, Denmark; Copenhagen University Hospital, Denmark; Endometriose Foreningen
• Investigators: Study Chair: Axel Forman, Aarhus University Hospital; Study Director: Lene Vase, University of Aarhus; Principal Investigator: Karina E Hansen, University of Aarhus

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Endometriosis; Pelvic Pain
• Other Study ID Numbers: AUENDO