Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Bedridden and agitated patients hospitalized in a neurosurgery department
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Time frame
day 12
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Time frame
day 23
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Time frame
day 34
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Time frame
day 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov