NCT07335575

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 29, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

Physical RestraintEmergency departmentsPatient safety

Outcome Measures

Primary Outcomes (1)

  • Proportion of cases in accordance with best practice recommendations (in %)

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

April 29, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 29, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations