Pets Enhancing Therapeutics in Intensive Care Units
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient aged 18 years or older,
Admitted to one of the participating ICUs at Clermont-Ferrand University Hospital (Estaing Adult ICU, Montpied Medical-Surgical ICU, or Montpied Neuro-ICU) with an expected ICU stay of 48 hours or more,
Owner of a companion dog, with family members or relatives able to bring the dog to the ICU.
Disqualifiers
Refusal by the patient or by their family/relatives to participate,
Lack of affiliation with the French national health insurance system (Sécurité Sociale),
Patient deprived of liberty or under legal protection (guardianship, curatorship, or judicial safeguard),
Pregnant or breastfeeding patient,
Trial design
Design model
Single group
Treatments tested in this trial
Pet dog visit
Other interventionPet 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.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Pet dog visitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Immediately after the interventionSecondary outcomes
1
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.)
Time frame
Immediately after the intervention2
Patient-related safety events regarding infections
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)
Time frame
ICU discharge (within a maximum of 28 days)3
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.
Time frame
Immediately after the intervention4
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.
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov
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