The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.
NCT ID: NCT06821217
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
308 participants
INTERVENTIONAL
2024-03-01
2027-08-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group with histologically confirmed endometriosis
NALU 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.
Control group with histologically confirmed endometriosis
No interventions assigned to this group
Intervention group with clinically suspected endometriosis
NALU 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.
Control group with clinically suspected endometriosis
No interventions assigned to this group
Interventions
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NALU 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Marietta Gulz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Insel Gruppe AG
Locations
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Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-D0105
Identifier Type: -
Identifier Source: org_study_id
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