Clinical trial NCT02761382: Psychological Pain Treatment in Endometriosis
Official title: Mindfulness-based Psychological Pain Treatment in Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Chronic Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: TrygFonden, Denmark
name: Copenhagen University Hospital, Denmark
name: Endometriose Foreningen
First posted: 2016-05-04
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Pelvic pain measured on Numeric Rating Scale
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
Secondary outcomes:
measure: Quality of life measured by the Endometriosis Health Profile 30 questionnaire
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
measure: Endometriosis related symptoms measured on Numeric Rating Scale
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
measure: Pain acceptance measured by Chronic Pain Acceptance Questionnaire
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
measure: Work Ability measured by the Work Ability Index
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
measure: Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
Other outcomes:
measure: Psychological flexibility measured by the Acceptance and Action Questionnaire-II
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
measure: Mindfulness measured by the Five Facet Mindfulness Questionnaire
timeFrame: Change from pre-intervention to post-intervention (12 weeks)
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Department of Obstetrics and Gynecology
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Department of Gynaecology
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Axel Forman
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Lene Vase
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Karina E Hansen
role: PRINCIPAL_INVESTIGATOR
References: