Actively Recruiting
A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-02-14
308
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether an app-based intervention can improve quality of life and relieve pain in women with suspected or confirmed endometriosis. This randomized controlled trial aims to compare the effects of using the app to a control group without app use over six months. The study is sponsored by Insel Gruppe AG, University Hospital Bern, and focuses on how digital support may aid women managing endometriosis symptoms. Participants in the experimental groups will use the NALU Endo Flow App, which offers educational videos, audios, and texts about endometriosis, including symptoms, diagnosis, and treatment options like lifestyle changes, diet, and mindfulness exercises. The app also features a menstrual cycle and symptom diary, access to a WhatsApp community, monthly peer-group calls, and Q&A sessions with certified health coaches. The control groups will not use the app during the study period. During the study, participants will complete quality of life questionnaires at the start, 1 month, 3 months, and 6 months. They will have either in-person visits or telephone consultations at 3 and 6 months. Researchers will monitor quality of life and pain relief over the six-month period to assess the app's impact on endometriosis-related symptoms and overall well-being.
CONDITIONS
Brief Title
The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Female, age 18 or older
- Premenopausal status (no menstrual absence lasting one year or longer)
- Endometriosis confirmed by surgery or clinically suspected
- Owns a smartphone
You will not qualify if you...
- Planned endometriosis surgery or hormonal therapy during the study period
- Surgery or new hormonal therapy within the last three months
- Malignant diseases
- Pregnancy
- Breastfeeding
- Active desire for pregnancy during the study period
- Undergoing fertility treatment
- Participation in other intervention studies at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 6 months
Participants use the NALU Endo Flow App, which provides educational content, symptom tracking, and access to peer support through calls and a community.
Monthly peer-group and Q&A calls; app use as needed
Trial Site Locations
Total: 1 location
1
Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
M
Marietta Gulz, MD
M
Michael David Mueller, Professor, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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