- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06121050
Can a Patient in Intensive Care be Visited by His or Her Pet? (ACCOMPAGNE)
Can a Patient in Intensive Care be Visited by His or Her Pet? Feasibility Study.
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume THIERY, PhD
- Phone Number: 33 0477127862
- Email: guillaume.thiery@chu-st-etienne.fr
Study Contact Backup
- Name: Cindy POKRANDT
- Email: Cindy.POKRANDT@chu-st-etienne.fr
Study Locations
-
-
-
Annonay, France, 07100
- Not yet recruiting
- Centre Hospitalier Ardeche Nord
-
Contact:
- Vincent CADIERGUE, MD
- Email: vincent.cadiergue@ch-ardeche-nord.fr
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Contact:
- Nathalie LESAINE
- Email: nathalie.lesaine@ch-ardeche-nord.fr
-
Principal Investigator:
- Vincent CADIERGUE
-
Sub-Investigator:
- Nathalie LESAINE
-
Saint-Etienne, France, 42055
- Recruiting
- CENTRE HOSPITALIER DE SAINT-ETIENNE
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Principal Investigator:
- Guillaume THIERY, PhD
-
Sub-Investigator:
- Cindy POKRANDT
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Contact:
- gaelle GUETON, CRA
- Email: gaelle.gueton@chu-st-etienne.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pet visit
Intensive care patients visited by their pets for 20 minutes
|
Intensive care patients visited by their pets for 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of visiting the pets
Time Frame: Day 15
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PANAS
Time Frame: Day 1
|
The impact of the animal's visit on the patient's mood will be assessed by variations in the scale Positive and Negative Affect Schedule (PANAS).
This self-report scale measures positive (PA) and negative (NA) affect, and is made up of 20 items, 10 of which assess PA and 10 of which assess NA.
Each item refers to an adjective, and responses are classified on a 5-point Likert scale, according to how the person felt about the emotion described by the adjective.
For each patient, the variation in AP and NA is calculated as follows: (score after visit-score before visit)/score before visit.
|
Day 1
|
|
Paramedical care
Time Frame: Day 1
|
The evaluation of the paramedical care load will be assessed by 2 quantitative indicators:
|
Day 1
|
|
Patient microbiological impact
Time Frame: Day 1
|
Search for multi-resistant bacteria on rectal and nasal swabs taken from patients on a routine weekly basis (Meticillin-resistant Staphylococcus Aureus, ESBL-producing Enterobacteria, Vancomycin-resistant Enterococcus, Carbapenemase-producing Enterobacteria). Stool analysis, in particular for Clostridium Difficile and Salmonella, and bacterial and parasitic research by multiplex PCR. |
Day 1
|
|
Intensive care unity microbiological impact
Time Frame: Day 1
|
Surface samples will be taken in conjunction with the operational hygiene team before and after the animal visit, in the room where the visit takes place, in the room of each patient included after discharge, and in the care areas of the intensive care unit.
These samples will focus on bacteria, fungi and parasites.
|
Day 1
|
|
Patient satisfaction
Time Frame: 3 months
|
Satisfaction survey
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cindy POKRANDT, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21PH263
- 2023-A01439-36 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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