Status:
RECRUITING
MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to assess the effect of a digital mindfulness- and acceptance-based psychological intervention on quality of life, work ability, pain experience and physical and mental hea...
Eligibility Criteria
Inclusion
- ≥18 years old.
- Signed informed consent.
- Endometriosis diagnosed by a gynecologist based on the medical case history, ultrasound, laparoscopy, or MRI (all self-reported).
- Moderate to severe symptoms (pelvic pain and/or fatigue measured on an 11-point numeric rating scale (NRS) from 0 = no pain/fatigue to 10 = worst imaginable pain/fatigue symptom) or reduced endometriosis-related quality of life (measured by the EHP-30):
- Moderate to severe endometriosis-related chronic pelvic pain (NRS \> 2) or
- Moderate to severe endometriosis-related fatigue (NRS \> 2) or
- Low endometriosis-related quality of life (one or more EHP-30 subscale mean scores ≥ 40.00).
- Relevant clinical and/or surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis has been attempted.
- Willingness to practice mindfulness and yoga at home for 30-45 minutes 5-7 days a week during the treatment period.
Exclusion
- Under 18 years old.
- Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment.
- Pregnancy or planned pregnancy during the study period.
- An estimated lack of capacity or surplus energy to enter into a digital mindfulness treatment, for instance, because of:
- major life events taking place at the same time (e.g., divorce, loss of a close relative, etc.)
- linguistic or cultural barriers
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT06211231
Start Date
February 7 2024
End Date
December 31 2026
Last Update
April 3 2024
Active Locations (2)
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1
Aarhus University Hospital, Department of Gynaecology and Obstetrics
Aarhus, Central Jutland, Denmark, DK-8000
2
The Danish Endometriosis Patients Association
Billund, Denmark, DK-7190