Study of Good Clinical Practice Regarding the Use of Physical Restraints in the Emergency Departments of Strasbourg University Hospital (PR)

January 2, 2026 updated by: University Hospital, Strasbourg, France
Physical restraint in healthcare settings is an ethical issue. The question of deprivation of liberty, as posed by this practice, has persisted throughout history. In psychiatric wards, physical restraint is governed by strict regulations, enshrined in the Public Health Code. This legal framework is absent from the investigator's emergency departments, despite their frequent involvement in the use of restraint. Several studies have highlighted risk factors associated with restraint. These studies have also highlighted the risks associated with restraint. A best practice guideline published by the French Society of Emergency Medicine (SFMU) in 2021 has provided guidelines for practices within our emergency departments. The objective of this study is to determine whether this guideline is followed by practitioners in the emergency departments of Strasbourg University Hospital. The investigators will also analyze the difference between cases that comply with the recommendations and those that do not. Analyses will also be conducted on the subjects most at risk of restraint, the experiences of restrained patients, the times of day when physical restraint is most likely to be applied, the reasons for restraint, and the nature of the physical and chemical restraint.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

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

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Urgences Médico-Chirurgicales Adules - CHU de Strasbourg - France
        • Sub-Investigator:
          • François LEFEBVRE, Statistician
        • Contact:
        • Principal Investigator:
          • François Will, MD
        • Sub-Investigator:
          • Barbara DEHAENE, 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patient (≥18 years) who was restrained during their visit to the University Hospital's emergency department between January 1, 2023, and June 30, 2023.

Description

Inclusion Criteria:

  • Adult patient (≥18 years)
  • Patient who was restrained during their visit to the University Hospital's emergency department between January 1, 2023, and June 30, 2023.

Exclusion Criteria:

Subject (and/or their legal representative, if applicable) must have expressed their objection to the reuse of their data for scientific research purposes.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of cases in accordance with best practice recommendations (in %)
Time Frame: Up to 6 months
Proportion of cases in accordance with the best practice guidelines of the French Society of Emergency Medicine (SFMU) among all patient cases that underwent physical restraint in the emergency department of the University Hospital over a 6-month period
Up to 6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

April 29, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 29, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9687

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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