- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06121050
Kan en patient på intensivvård få besök av sitt husdjur? (ACCOMPAGNE)
Kan en patient på intensivvård få besök av sitt husdjur? Förstudie.
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.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Guillaume THIERY, PhD
- Telefonnummer: 33 0477127862
- E-post: guillaume.thiery@chu-st-etienne.fr
Studera Kontakt Backup
- Namn: Cindy POKRANDT
- E-post: Cindy.POKRANDT@chu-st-etienne.fr
Studieorter
-
-
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Annonay, Frankrike, 07100
- Har inte rekryterat ännu
- Centre Hospitalier Ardèche Nord
-
Kontakt:
- Vincent CADIERGUE, MD
- E-post: vincent.cadiergue@ch-ardeche-nord.fr
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Kontakt:
- Nathalie LESAINE
- E-post: nathalie.lesaine@ch-ardeche-nord.fr
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Huvudutredare:
- Vincent CADIERGUE
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Underutredare:
- Nathalie LESAINE
-
Saint-Etienne, Frankrike, 42055
- Rekrytering
- Centre Hospitalier de Saint-Etienne
-
Huvudutredare:
- Guillaume THIERY, PhD
-
Underutredare:
- Cindy POKRANDT
-
Kontakt:
- gaelle GUETON, CRA
- E-post: gaelle.gueton@chu-st-etienne.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Pet visit
Intensive care patients visited by their pets for 20 minutes |
Intensive care patients visited by their pets for 20 minutes |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of visiting the pets
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PANAS
Tidsram: 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
Tidsram: Day 1
|
The evaluation of the paramedical care load will be assessed by 2 quantitative indicators:
|
Day 1
|
|
Patient microbiological impact
Tidsram: 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
Tidsram: 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
Tidsram: 3 months
|
Satisfaction survey |
3 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Cindy POKRANDT, Centre Hospitalier Universitaire de Saint Etienne
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 21PH263
- 2023-A01439-36 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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