Clinical trial Recruiting at 1 site Observational Ages 18 and up

Detecting risky behaviors in agitated, bedridden neurosurgery patients

Official title: Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.

Run by University Hospital, Clermont-Ferrand · NCT05522647 · Data updated 2026-11-12

This project will try to detect and record risky behaviors in hospitalized bedridden patients who are agitated or confused so clinicians can understand how often and what types occur.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity Hospital, Clermont-Ferrand
Academic / other
Locations1 site (Clermont-Ferrand)
StatusRecruiting
StartedJuly 9, 2025
Main results expectedJuly 9, 2026
Study endsJuly 31, 2026
Registry record updatedJuly 14, 2025
Trial IDNCT05522647 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are bedridden neurosurgery inpatients at CHU Clermont-Ferrand with neurological or cognitive disorders causing agitation or confusion who will remain hospitalized for at least nine days and who (or whose trusted person) can provide consent.

Probably not a fit

Patients with acute or transient somatic agitation (for example from pain or metabolic disturbance), those under guardianship/curatorship, pregnant or breastfeeding women, or anyone who refuses participation are unlikely to benefit from this project.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot observational project conducted in the neurosurgery department at CHU Clermont-Ferrand that will continuously observe bedridden patients who display agitation or confusion. Eligible patients are those hospitalized at least nine days with neurological or cognitive disorders leading to agitation, and participation requires patient or trusted-person consent. Observers will document the nature and frequency of risk behaviors and related events such as use of physical or chemical restraints, falls, and required additional examinations. The collected descriptive data aim to clarify patterns of endangerment for patients and emotional and economic impacts for caregivers and the hospital.

Why it matters

Potential benefit: If successful, the findings could help staff identify common risky behaviors and timing so they can reduce falls, unnecessary restraints, and related harms.

How similar studies have gone: While observational work on falls and agitation exists, detailed bedside characterization of risk behaviors specifically in bedridden neurosurgery patients is relatively underexplored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
* Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
* Affiliation to a social security system
* Hospitalization in the department for at least 9 days
* Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research

Exclusion Criteria:

* Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
* Patient under guardianship, curatorship or safeguard of justice
* Pregnant and breastfeeding women
* Refusal to participate

Where it's running

  • CHU clermont-ferrand
    Clermont-Ferrand, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.