Pets Enhancing Therapeutics in Intensive Care Units

Official title

Visits by Pet Dogs to Patients Admitted to Intensive Care at the Clermont-Ferrand University Hospital: Feasibility Study

Overview

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.

Interventions

• Other Pet dog visit
  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.

Primary outcome measures

• Success of the pet dog visit [Time frame: Immediately after the intervention]

Secondary outcome measures (10)

• Patient-related safety events regarding inconvenience or harm [Time frame: Immediately after the intervention]
• Patient-related safety events regarding infections [Time frame: ICU discharge (within a maximum of 28 days)]
• Dog-related events regarding aggression or behavioral issues [Time frame: Immediately after the intervention]
• Staff-related events regarding inconvenience or harm [Time frame: Immediately after the intervention]
• Visit conditions in the case of success (excluding the safety criteria listed above) [Time frame: Immediately after the intervention]
• Reasons for potential visit failure (defined as the inability to bring the animal into the patient's ICU room) [Time frame: Immediately before the intervention]
• Pre-visit ICU staff satisfaction-related survey [Time frame: Immediately before the intervention]
• Post-visit ICU staff satisfaction-related survey [Time frame: Immediately after the intervention]
• Post-visit satisfaction survey of the patient's relative(s) who accompanied the dog [Time frame: Immediately after the intervention]
• Patient satisfaction survey [Time frame: ICU discharge (within a maximum of 28 days)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

Patient-related exclusion criteria:

• 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,
• Agitated patient, defined as a Richmond Agitation-Sedation Scale (RASS) score > 0 (monitored every four hours according to current standard practice),
• Patient with immunosuppression, defined as: blood neutrophil count < 0.5 G/L, ongoing or recent (within the past month) treatment for solid or hematologic cancer (e.g., chemotherapy, radiotherapy, cell therapy), or receiving immunosuppressive drugs (including organ transplant recipients or corticosteroid therapy for more than two weeks),
• Patient with known colonization by multidrug-resistant bacteria (as routinely assessed upon ICU admission and weekly thereafter),
• Patient with one or more open wounds or injuries that cannot be covered with a dressing.

Dog-related exclusion criteria:

• Dog belonging to category 1 or 2 breeds considered dangerous under current French regulations,
• Dog that never leaves the home environment,
• Dog with an incomplete vaccination status,
• Dog with a known transmissible disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07159568 · AOI 2024 LALANDE · 2025-A00615-44

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗