Pets Enhancing Therapeutics in Intensive Care Units

NCT07159568 | Not Yet Recruiting

• 2 other identifiers: AOI 2024 LALANDE2025-A00615-44
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intensive Care Unit (ICU) Patients; Dog Therapy

Keywords

dog therapy

Outcome Measures

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

  Immediately after the intervention

Secondary Outcomes (10)

• Patient-related safety events regarding inconvenience or harm

  Immediately after the intervention

• Patient-related safety events regarding infections

  ICU discharge (within a maximum of 28 days)

• Dog-related events regarding aggression or behavioral issues

  Immediately after the intervention

• Staff-related events regarding inconvenience or harm

  Immediately after the intervention

• Visit conditions in the case of success (excluding the safety criteria listed above)

  Immediately after the intervention

Study Arms (1)

Pet dog visit

EXPERIMENTAL

Other: Pet dog visit

Interventions

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.

Pet dog visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Study Officials

• Matthieu Jabaudon, MD, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

04.73.75.49.63; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)