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

NCT ID: NCT05522647

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-09

Study Completion Date

2026-07-31

Brief Summary

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There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.

The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.

Detailed Description

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Conditions

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Risk Behavior Agitation Hospitalization Bedridden Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlène DUBOIS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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2021-A03099-32

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2021 DUBOIS

Identifier Type: -

Identifier Source: org_study_id

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