Psychological Pain Treatment in Endometriosis

Chronic Pain Clinical Trial

Official title:

Mindfulness-based Psychological Pain Treatment in Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761382
• Other study ID #: AUENDO
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: June 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis
• Pelvic Pain

Intervention

Other:
• Mindfulness-based psychological treatment

• Non-specific psychological treatment

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Obstetrics and Gynecology	Aarhus N
Denmark	Copenhagen University Hospital, Department of Gynaecology	Copenhagen
Denmark	North Denmark Regional Hospital	Hjørring

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Copenhagen University Hospital, Denmark, Endometriose Foreningen, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)