Physical RestraintNCT06491706
Long-term Outcomes in Older Patients With Physical Restraint
An observational study of Physical Restraint and Gender Bias, run by Beaujon Hospital at 1 site in France.
Trial summary
The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Restraint, Gender Bias, Morality
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All consecutive older patients ≥ 75-year-old
Who may be able to join
- All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED
- If physical restraint were mentioned in medical records
Who cannot join
- if patients were less than 75 years old
- Without physical restraint
- Not hospitalized
- If a patient was admitted more than once, only the first episode was taken as index admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department
The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.
This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.
Read more
This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.
The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.
- Conditions
- Physical Restraint, Gender Bias, Morality
- Being tested
- the was no intervention
- Keywords
- physical restraint, emergency department, biological sex, long-term mortality
- Medical subject headings
- Sexism, Emergencies, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the was no interventionOther
there was no intervention in this observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
one year mortaliy
Measured: ONE year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Nov 2019
- Primary completion31 Mar 2021
- Study completion30 Oct 2022
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prabakar VAITTINADA AYAR, Beaujon Hospital
- Investigators
- Prabakar VAITTINADA AYAR, MD, PhD, Principal investigator, Hôpital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491706
- Sponsor's protocol ID
- urgBjNpr
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department
- ClinicalTrials.gov ID
- NCT06491706
- Acronym / sponsor ID
- urgBjNpr
- Conditions
- Physical Restraint, Gender Bias, Morality
- Keywords
- physical restraint, emergency department, biological sex, long-term mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 9 Jul 2024 (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.
The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.
This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.
This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.
The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All consecutive older patients ≥ 75-year-old
Key inclusion criteria (2 listed)
- All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED
- If physical restraint were mentioned in medical records
Key exclusion criteria (4 listed)
- if patients were less than 75 years old
- Without physical restraint
- Not hospitalized
- If a patient was admitted more than once, only the first episode was taken as index admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the was no interventionthere was no intervention in this observational study | Other | – |
Primary outcome
one year mortaliy
Time frame: ONE year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Prabakar VAITTINADA AYAR, MD, PhD principal investigator
Hôpital Beaujon
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 and Gender Bias, run by Beaujon Hospital 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 4 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: finished, as of the sponsor's last update on 25 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year mortaliy (time frame: ONE year). 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 25 Jul 2025.