Clinical trial NCT05522647: Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
Official title: Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Risk Behavior
Agitation
Hospitalization
Bedridden Patients
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bedridden and agitated patients hospitalized in a neurosurgery department

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 1
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 2
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 3
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 4
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 5
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 6
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 7
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 8
measure: Number of risk behaviors observed per one-hour period
timeFrame: day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Charlène DUBOIS
role: PRINCIPAL_INVESTIGATOR
References: