Intensive Care Unit (ICU) PatientsPET-ICUNCT07159568
Pets Enhancing Therapeutics in Intensive Care Units
A study testing Pet dog visit in people with Intensive Care Unit (ICU) Patients and Dog Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit (ICU) Patients, Dog Therapy
- What is being tested?
- Pet dog visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2025to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Matthieu Jabaudon, MD, PhD
About this study
Official title: Visits by Pet Dogs to Patients Admitted to Intensive Care at the Clermont-Ferrand University Hospital: Feasibility Study
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
- Being tested
- Pet dog visit
- Keywords
- dog therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet dog visitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pet dog visit | Experimental | Not described Receives: Other: Pet dog visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the intervention
Secondary outcomes (10)
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.)
Measured: Immediately after the intervention
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 :
- Non-compliance with local hygiene guidelines and pre-/intra-visit checklists, as developed specifically for this protocol in collaboration with the hospital's infection control team (CLIN).
- Non-compliance with local veterinary regulations and pre-visit veterinary checklists as defined in the study protocol (e.g., vaccination status, parasite control, and regular veterinary follow-up).
- Patient agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score > 0 (monitored every 4 hours per standard practice), before or during the visit.
- Any other reason preventing the animal from entering the ICU or the patient's room before or during the visit (including patient discharge from ICU before the visit could be scheduled).
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention
Post-visit satisfaction survey of the patient's relative(s) who accompanied the dog
Measured: Immediately after the intervention
Patient satisfaction survey
Measured: ICU discharge (within a maximum of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU) PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Jabaudon, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159568
- Sponsor's protocol ID
- AOI 2024 LALANDE
- Other IDs
- 2025-A00615-44
- Acronym
- PET-ICU
- Status last verified
- Jul 2025
- First submitted
- 27 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visits by Pet Dogs to Patients Admitted to Intensive Care at the Clermont-Ferrand University Hospital: Feasibility Study
- ClinicalTrials.gov ID
- NCT07159568
- Acronym / sponsor ID
- PET-ICU / AOI 2024 LALANDE
- Conditions
- Intensive Care Unit (ICU) Patients, Dog Therapy
- Keywords
- dog therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pet dog visit | Experimental | Other: Pet dog visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pet dog visitPet 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. | Other | Pet dog visit |
Primary outcome
Success of the pet dog visit
Time frame: Immediately after the intervention
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
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthieu Jabaudon, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet dog visit in people with Intensive Care Unit (ICU) Patients and Dog Therapy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (04.73.75.49.63, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the pet dog visit (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.