NCT06211231Recruiting
MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- First submitted
- 8 Jan 2024
- Start date
- 7 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Aarhus
- Diseases
- Endometriosis
- NCT number
- NCT06211231
What you commit to
- Study type: Interventional
- Planned participants: 255
- From 7 Feb 2024 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment.
Age
- Under 18 years old.
Other
- 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
Who the study is looking for
- ≥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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, Department of Gynaecology and Obstetrics Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| The Danish Endometriosis Patients Association Coordinator of this site? Confirm its status | Billund | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.