RecruitingNot ApplicableNCT06211231

MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program


Sponsor

University of Aarhus

Enrollment

255 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

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 health in participants experiencing chronic pain, fatigue and/or reduced quality of life due to endometriosis.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria9

  • ≥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 Criteria6

  • 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

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Interventions

BEHAVIORALDigitally delivered mindfulness- and acceptance-based psychological intervention

MY-ENDO is developed specifically for endometriosis and includes ten themes; one for each session: 1) endometriosis, 2) chronic pain and pain mechanisms, 3) stress, 4) thoughts and feelings, 5) grief, 6) identity and meaning, 7) everyday life and relations, 8) health, diet and exercise, 9) value-based action and 10) a good life with endometriosis.


Locations(2)

Aarhus University Hospital, Department of Gynaecology and Obstetrics

Aarhus, Central Jutland, Denmark

The Danish Endometriosis Patients Association

Billund, Denmark

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NCT06211231


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