MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
Recruiting · NCT06211231 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
Digitally delivered mindfulness- and acceptance-based psychological intervention
What this trial is about
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 health in participants experiencing chronic pain, fatigue and/or reduced quality of life due to endometriosis.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥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 criteria
- 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
Where it is running
2 locations listed.
- The Danish Endometriosis Patients Association - Billund, Denmark
- Aarhus University Hospital, Department of Gynaecology and Obstetrics - Aarhus, Central Jutland, Denmark