NCT06121050

Brief Summary

Nearly half of all intensive care patients describe symptoms of anxiety and depression after a stay in the ICU, and one in five has genuine post-traumatic stress disorder. As a result, improving patient experience has become a priority in the ICU, and particular attention is being paid to the need to recreate a familiar environment. Animal-mediated interventions have been developed for a number of patients over many years. These strategies are widely used with elderly patients, and patients with cognitive or psychiatric disorders, for whom the literature shows benefits on anxiety, mood or objective signs of stress. In the vast majority of experiments carried out to date, the animals (mainly dogs) were prepared and educated for contact with patients, and their handlers trained in this activity, rather like guide dogs. Visiting a care facility with a patient's own pet is rarely described. It may run up against obstacles related to the animal's behavior or infectious risks, but it is nevertheless authorized in many establishments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
38mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jul 2025Jun 2029

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

November 2, 2023

Last Update Submit

July 3, 2025

Conditions

Intensive Care Patients

Outcome Measures

Primary Outcomes (1)

  • Feasibility of visiting the pets

    The feasibility of visiting the pets of patients hospitalized in the intensive care unit will be measured by the proportion of patients included in the study for whom at least one visit with their pet was possible. A visit will be considered to have taken place as soon as the patient has had contact with his or her pet.

    Day 15

Secondary Outcomes (5)

  • PANAS

    Day 1

  • Paramedical care

    Day 1

  • Patient microbiological impact

    Day 1

  • Intensive care unity microbiological impact

    Day 1

  • Patient satisfaction

    3 months

Study Arms (1)

Pet visit

EXPERIMENTAL

Intensive care patients visited by their pets for 20 minutes

Other: Pet visit

Interventions

Pet visitOTHER

Intensive care patients visited by their pets for 20 minutes

Pet visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conscious adult patients with a pet (dog/cat).
  • Patients with no or no longer hemodynamic or respiratory failure, or undergoing rehabilitation, after resolution of the acute phase or at the end of life.
  • Patients affiliated to or entitled under a social security scheme.
  • Patient who has given written informed consent to participate in the study.

You may not qualify if:

  • Non-stabilized acute situation (as assessed by the resuscitator).
  • Mechanical or amine ventilation or extrarenal purification.
  • Tracheostomy.
  • Immunosuppression.
  • Carriage of multi-resistant bacteria.
  • Behavioral or consciousness disorders.
  • Pregnancy.
  • Skin wounds, extensive burns exceeding 15% of body surface area, external fixator.
  • Guardianship or trusteeship.
  • Workload incompatible with the visit
  • Patient unable to speak French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Ardèche Nord

Annonay, 07100, France

NOT YET RECRUITING

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Study Officials

  • Cindy POKRANDT

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume THIERY, PhD

CONTACT

0477127862guillaume.thiery@chu-st-etienne.fr

Cindy POKRANDT

CONTACT

Cindy.POKRANDT@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patients who can be visited by their pets
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

July 3, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations

FR(2)