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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group with histologically confirmed endometriosis | Experimental |
| |
| Control group with histologically confirmed endometriosis | No Intervention | ||
| Intervention group with clinically suspected endometriosis | Experimental |
| |
| Control group with clinically suspected endometriosis | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NALU Endo Flow App | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Life quality | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | 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". | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marietta Gulz, MD | Contact | +41 31 632 10 10 | marietta.gulz@insel.ch | |
| Michael David Mueller, Professor, MD | Contact | michel.mueller@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Marietta Gulz, MD | University Hospital Bern, Insel Gruppe AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern | Recruiting | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |