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

Not Applicable

Recruiting

• Conditions: Endometriosis; Pain; Quality of Life; Life Style

• Registration Number: NCT06821217
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Life quality	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain relief	6 months	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".

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern; 🇨🇭 Bern, Switzerland