Chronic Pain, Endometriosis, Pelvic Pain
Conditions
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).
Interventions
OTHERMindfulness-based psychological treatment
OTHERNon-specific psychological treatment
Sponsors
Aarhus University Hospital
TrygFonden, Denmark
Copenhagen University Hospital, Denmark
Endometriose Foreningen
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness measured by the Five Facet Mindfulness Questionnaire | Change from pre-intervention to post-intervention (12 weeks) | Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ) |
| Psychological flexibility measured by the Acceptance and Action Questionnaire-II | Change from pre-intervention to post-intervention (12 weeks) | Psychological flexibility will be measured by the Acceptance and Action Questionnaire-II (AAQ-II) |
Countries
Denmark
Outcome results
None listed