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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| TrygFonden, Denmark | INDUSTRY |
| Copenhagen University Hospital, Denmark | OTHER |
| Endometriose Foreningen |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based treatment | Experimental | 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:
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| Non-specific treatment | Experimental | 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:
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| Waiting list control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based psychological treatment | Other |
| ||
| Non-specific psychological treatment |
| 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) |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Forman | Aarhus University Hospital | Study Chair |
| Lene Vase | University of Aarhus | Study Director |
| Karina E Hansen | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Department of Obstetrics and Gynecology | Aarhus N | 8200 | Denmark | |||
| Copenhagen University Hospital, Department of Gynaecology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36797461 | Derived | Hansen KE, Brandsborg B, Kesmodel US, Forman A, Kold M, Pristed R, Donchulyesko O, Hartwell D, Vase L. Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial. Qual Life Res. 2023 Jun;32(6):1727-1744. doi: 10.1007/s11136-023-03346-9. Epub 2023 Feb 17. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| UNKNOWN |
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| Other |
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| 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) |
Mindfulness will be measured by the Five Facet Mindfulness Questionnaire (FFMQ) |
| Change from pre-intervention to post-intervention (12 weeks) |
| Copenhagen |
| 2100 |
| Denmark |
| North Denmark Regional Hospital | Hjørring | Denmark |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |