RecruitingNot ApplicableNCT06821217

The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.

A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

308 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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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.


Locations(1)

Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern

Bern, Switzerland

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NCT06821217


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