Physical RestraintPRNCT07335575
Study of Good Clinical Practice Regarding the Use of Physical Restraints in the Emergency Departments of Strasbourg University Hospital
An observational study of Physical Restraint, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Restraint
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2025to 29 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subject (and/or their legal representative, if applicable) must have expressed their objection to the reuse of their data for scientific research purposes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Urgences Médico-Chirurgicales Adules - CHU de Strasbourg - France
Strasbourg, 67091
François Will, MD, 33 3.88.11.54.67, francois.weill@chru-strasbourg.fr
François Will, MD
About this study
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.
- Conditions
- Physical Restraint
- Keywords
- Physical Restraint, Emergency departments, Patient safety
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start29 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical RestraintStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335575
- Sponsor's protocol ID
- 9687
- Acronym
- PR
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Good Clinical Practice Regarding the Use of Physical Restraints in the Emergency Departments of Strasbourg University Hospital
- ClinicalTrials.gov ID
- NCT07335575
- Acronym / sponsor ID
- PR / 9687
- Conditions
- Physical Restraint
- Keywords
- Physical Restraint, Emergency departments, Patient safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject (and/or their legal representative, if applicable) must have expressed their objection to the reuse of their data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Restraint, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Will, MD (33 3.88.11.54.67, francois.weill@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases in accordance with best practice recommendations (in %) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.