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NCT Number: NCT06821217

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

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Life Style Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Michael Mueller, Professor, MD

CONTACT

[email protected]

+41 31 632 10 10

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NALU Endo Flow App

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.

Primary outcomes

  1. Life quality

    Time frame: 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 outcomes

  1. Pain relief

    Time frame: 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Marietta Gulz, MD

CONTACT

[email protected]

+41 31 632 10 10

Michael David Mueller, Professor, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: MASQUE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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