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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
RECRUITING
Bern
Contact Information
Primary
Marietta Gulz, MD
marietta.gulz@insel.ch
+41 31 632 10 10
Backup
Michael David Mueller, Professor, MD
michel.mueller@insel.ch
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 308
Treatments
Experimental: Intervention group with histologically confirmed endometriosis
No_intervention: Control group with histologically confirmed endometriosis
Experimental: Intervention group with clinically suspected endometriosis
No_intervention: Control group with clinically suspected endometriosis
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov