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NCT Number: NCT07335575

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Urgences Médico-Chirurgicales Adules - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Barbara DEHAENE, MD

SUB_INVESTIGATOR

François LEFEBVRE, Statistician

SUB_INVESTIGATOR

François Will, MD

CONTACT

[email protected]

33 3.88.11.54.67

François Will, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

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

François Will, MD

CONTACT

[email protected]

33 3.88.11.54.67

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

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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