NCT05522647 Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
| NCT ID | NCT05522647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Risk Behavior |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2026-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-07-09 with a primary completion date of 2026-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Charlène DUBOIS
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT05522647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Risk Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05522647 currently recruiting?
Yes, NCT05522647 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT05522647 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT05522647 clinical trial?
NCT05522647 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Charlène DUBOIS at University Hospital, Clermont-Ferrand. The trial plans to enroll 20 participants.