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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00615-44 | Other Identifier | ANSM |
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Intensive Care Units (ICUs) are well known for their therapeutic and environmental aggressiveness. Current recommendations for the management of critically ill patients, including the "ABCDEF bundle," emphasize family engagement and liberal visitation policies for relatives and loved ones, with the aim of improving patient well-being during their ICU stay.
In France, half of all households own a pet. This close relationship between humans and animals explains why animals have long been involved in medical care. The earliest known use of animals in medicine dates back to the 9th century in Belgium, where they were used to assist individuals with mental illness. More recently, companion animal-assisted interventions have attracted growing interest due to their potential diagnostic and/or therapeutic value, as they may enhance the patient experience during hospitalization. The feasibility, safety, and potential benefits of pet visitation policies have mainly been assessed in conventional hospital wards, but remain understudied in the ICU setting. In France, to our knowledge, only three hospitals have allowed pet visits in the ICU, and these occurred outside of any research protocol.
The study primary objective is to assess the feasibility of companion dog visits in three medical-surgical ICUs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pet dog visit | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pet dog visit | Other | Pet dog visit will take place during dedicated time slots, following prior verification of the dog's hygiene criteria. The dog may stay in the patient's room for a maximum of 15 minutes. After the visit, an evaluation questionnaire will be completed by the healthcare staff and by the relative who accompanied the dog. The patient's evaluation questionnaire will be completed at ICU discharge if patient is able to respond, or at most 28 days after inclusion if the patient remains in the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of the pet dog visit | The success of the pet dog visit is defined as the entry of the animal into the patient's ICU room under the conditions specified in the study protocol | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-related safety events regarding inconvenience or harm | Any inconvenience or harm to the patient, regardless of nature (including accidental dislodgement or removal of medical equipment/devices such as tracheal tubes, catheters, drains, etc.) | Immediately after the intervention |
| Patient-related safety events regarding infections |
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Inclusion Criteria:
Exclusion Criteria:
Patient-related exclusion criteria:
Dog-related exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 04.73.75.49.63 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Matthieu Jabaudon, MD, PhD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
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New colonization with multidrug-resistant organisms (as assessed upon ICU admission and weekly thereafter); and new ICU-associated infections (as routinely screened according to standard care) |
| ICU discharge (within a maximum of 28 days) |
| Dog-related events regarding aggression or behavioral issues | Any display of aggression or behavioral issues (as defined by the participating veterinarian, e.g., stupor, withdrawal, uncontrolled barking, urination or defecation) during the ICU visit, regardless of whether the dog ultimately entered the patient's room. | Immediately after the intervention |
| Staff-related events regarding inconvenience or harm | Any inconvenience or harm to a member of the healthcare team, regardless of nature (e.g., injury, hygiene issues, noise, or behavioral disturbance) during the ICU visit, regardless of whether the dog ultimately entered the patient's room. | Immediately after the intervention |
| Visit conditions in the case of success (excluding the safety criteria listed above) | Precise duration of the visit in the patient's room (maximum of 15 minutes, as per protocol), any direct contact between the patient and the dog, and the nature of such interaction. | Immediately after the intervention |
| Reasons for potential visit failure (defined as the inability to bring the animal into the patient's ICU room) | Reasons are defined as :
| Immediately before the intervention |
| Pre-visit ICU staff satisfaction-related survey | Pre-visit survey of ICU staff (including all clinical and non-clinical personnel such as physicians, nurses, therapists, hygiene and cleaning staff, administrative assistants, and supervisors) to assess their opinions and any potential concerns regarding the visit. | Immediately before the intervention |
| Post-visit ICU staff satisfaction-related survey | Post-visit survey of the same ICU staff to assess their opinion and level of satisfaction. | Immediately after the intervention |
| Post-visit satisfaction survey of the patient's relative(s) who accompanied the dog | Immediately after the intervention |
| Patient satisfaction survey | ICU discharge (within a maximum of 28 days) |