Strategies of Self-management of Endometriosis Symptoms (SAGE)

November 27, 2023 updated by: Benno Rehberg-Klug

Strategies of Self-management of Endometriosis Symptoms: an Observational Study

To determine the prevalence and perceived utility of self-management strategies amongst patients with endometriosis and who consult the endometriosis clinic of the Geneva University Hospital, information about these strategies will be obtained via a web-based questionnaire.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genève HUG
        • Contact:
        • Contact:
        • Principal Investigator:
          • Domitille Dereu, MD
        • Sub-Investigator:
          • Claudia Benvenuti, MD
        • Sub-Investigator:
          • Leen Aerts, MD
        • Sub-Investigator:
          • Nicola Pluchino, MD
        • Sub-Investigator:
          • Elodie Obrist, MD
        • Sub-Investigator:
          • Benno Rehberg-Klug, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all patients consulting at a specialised centre

Description

Inclusion Criteria:

  • patients consulting at the endometriosis clinic of the HUG
  • minimum 18 years
  • capacity to answer the questions of the questionnaire

Exclusion Criteria:

  • minor patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of use of any self-management strategy
Time Frame: during the last 6 months prior to the questionnaire
binary answer: yes/no of use
during the last 6 months prior to the questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of use of the pre-specified strategies: gymnastics, rest, hypnosis, meditation, exercise, osteopathy, cold/warm, acupuncture, CBD, cannabis, alcohol, TENS, phytotherapy, curcuma, essential oils, diet
Time Frame: during the last 6 months prior to the questionnaire
binary answer: yes/no of use
during the last 6 months prior to the questionnaire

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
perceived efficacy of the different strategies of self-management
Time Frame: during the last 6 months prior to the questionnaire
0-10 scale for pain and 5 classes for other symptoms (none, little, medium, large, very large)
during the last 6 months prior to the questionnaire
perceived reduction of analgesic use by the different strategies of self-management
Time Frame: during the last 6 months prior to the questionnaire
5 classes (none, little, medium, large, very large)
during the last 6 months prior to the questionnaire
side effects of the different strategies of self-management
Time Frame: during the last 6 months prior to the questionnaire
free text
during the last 6 months prior to the questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benno Rehberg-Klug

Investigators

  • Study Director: Benno Rehberg-Klug, MD, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 19, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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