Digital mindfulness program for managing endometriosis
MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
This study is testing a digital mindfulness program to see if it can help people with endometriosis manage their pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 255 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus, Central Jutland and 1 other locations) |
| Trial ID | NCT06211231 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a digital mindfulness and acceptance-based psychological intervention aimed at improving quality of life, work ability, and pain management in individuals suffering from endometriosis. Participants will engage in a structured program that includes mindfulness practices and yoga, delivered digitally, over a specified treatment period. The intervention targets those experiencing chronic pain, fatigue, and reduced quality of life due to their condition, with assessments conducted to measure outcomes related to physical and mental health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of endometriosis and moderate to severe symptoms.
Not a fit: Patients with mild symptoms or those who have not attempted relevant clinical or surgical treatments may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life and pain management for patients with endometriosis.
How similar studies have performed: Previous studies have shown promise in using mindfulness-based interventions for chronic pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus, Central Jutland and 1 other locations
- Aarhus University Hospital, Department of Gynaecology and Obstetrics — Aarhus, Central Jutland, Denmark (Recruiting)
- The Danish Endometriosis Patients Association — Billund, Denmark (Recruiting)
Study contacts
- Principal investigator: Henrik Marschall, MSc — University of Aarhus
- Study coordinator: Henrik Marschall, MSc
- Email: hmars@psy.au.dk
- Phone: +4522394563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.