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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis Pain Quality of Life Life Style

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group with histologically confirmed endometriosis

Group Type EXPERIMENTAL

NALU Endo Flow App

Intervention Type DEVICE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group with clinically suspected endometriosis

Group Type EXPERIMENTAL

NALU Endo Flow App

Intervention Type DEVICE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marietta Gulz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bern, Insel Gruppe AG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Bern, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marietta Gulz, MD

Role: CONTACT

+41 31 632 10 10

Michael David Mueller, Professor, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael Mueller, Professor, MD

Role: primary

+41 31 632 10 10

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-D0105

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.