Endometriosis, Life Style, Pain, Quality of Life
Conditions
Brief summary
The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are: * Does the App-based intervention improve the quality of life? * Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms. Participants will: * Use an App-based intervention or be in the control group (no App-use) for 6 months * Visit or have a telephone consultation after 3 and 6 months * Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months
Interventions
DEVICENALU Endo Flow App
NALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q&A (Question&Answer) call moderated by certified health coaches.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature * Age 18 or older * Premenopausal status (menopause is defined as amenorrhea lasting one year or longer) * Endometriosis, confirmed by surgery or clinically suspected * Possession of a smartphone
Exclusion criteria
* Planned endometriosis surgery or planned hormonal therapy in the study period * Surgery and/or new hormonal therapy in the last three months * Malignant diseases * Pregnancy * Breastfeeding * Active desire for pregnancy in the study period * Fertility treatment * Simultaneous participation in other intervention studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life quality | 6 months | The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | 6 months | The secondary endpoint of this study is the change in pain intensity in App users measured by the VAS (Visual Analogue Scale). The VAS is one of various instruments to measure pain intensity. A score of 0 means no pain, a score of 10 the worst imaginable pain. |
Countries
Switzerland
Contacts
Primary ContactMarietta Gulz, MD
Backup ContactMichael David Mueller, Professor, MD
Outcome results
None listed