Clinical trial

Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study

Name

69HCL18_0804

Description

Assisted animal therapy (AAT) is getting more and more used worldwide, in such areas as gerontology, psychiatry, or oncology. It is a complementary therapy, and benefits for patients are various, including decrease of anxiety. In ICU, some case reports exist, but no study has ever been made in order to prove its benefits, not even its feasibility. In ReAnimal, the investigator aims to compare a group of patients receiving assisted animal therapy, versus a group of patients not receiving it. Primary objective will be the evolution of anxiety scores between the 2 groups of patients. Secondary objectives will be the comparison of mood scores, post traumatic stress syndrome scores, pain scores, and physiologic parameters such as blood pressure, cardiac frequency. The investigating team will also compare multi drug resistant bacteria incidence between the 2 groups. In the assisted animal therapy group, patients will also be asked to answer a satisfaction questionnaire.

Trial arms

Trial start

2020-09-18

Estimated PCD

2022-08-24

Trial end

2022-08-24

Status

Terminated

Treatment

Animal assisted therapy

Patients of AAT group will leave their hospital bedroom to go in the session room, where they will meet a dog, who has come with his veterinary student master. Animal assisted therapy session will last at most 20 minutes, in which the patient is going to interact with the dog, pet him, play with him, etc.

Arms:

Animal assisted therapy group

Nasal swab sampling

All patients will have nasal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria

Arms:

Animal assisted therapy group, Control Group

STAI-Y and POMS Questionnaires

Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.

Arms:

Animal assisted therapy group, Control Group

physiological parameters measure

Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.

Arms:

Animal assisted therapy group, Control Group

Visual Analog Scale (VAS)

Before and after AAT or sham session, pain will be evaluated thanks to VAS

Arms:

Animal assisted therapy group, Control Group

Impact of Event Scale - Revised (IES-R)

Patients will answer IES-R questionnaire 3 months after AAT or sham session

Arms:

Animal assisted therapy group, Control Group

satisfaction questionnaire

Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT

Arms:

Animal assisted therapy group

Rectal swab sampling

All patients will have rectal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria

Arms:

Animal assisted therapy group, Control Group

Size

Primary endpoint

State-Trait Anxiety Inventory Y (STAI-Y) score

Before randomization

State-Trait Anxiety Inventory Y (STAI-Y) score

2 days after inclusion, before AAT or sham session

State-Trait Anxiety Inventory Y (STAI-Y) score

2 days after inclusion, after AAT or sham session

Eligibility criteria

Inclusion Criteria: * patients hospitalized in surgical ICU, not in acute stage of their ICU stay * adult patient * able to receive information and to give consent, * with national social insurance Exclusion Criteria: * afraid of animal, dog phobia * allergic to dog * immunodepression (neutrophils \<0.5 G/L), induced by treatment (chemotherapy, immunosuppressing treatment with high doses, corticotherapy for more than 2 weeks) or induced by disease (malignant blood disease, AIDS, transplantation, or splenectomy) * sepsis ongoing * patient known for having multidrug resistant bacteria * wounds, or large bandages that could not correctly be covered, including external fixer * central venous catheter, arterial catheter * tracheostomy * agitation, aggressiveness * pregnant women * patient deprived of freedom by juridical or administrative decision * patient under legal protection measure * patient receiving enforced psychiatric treatment * patient admitted in a sanitary or social department.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

Updated at

2023-05-26

1 organization

2 products

3 indications

Organization

Hospices Civils de Lyon

Product

Nasal swab sampling

Indication

Anxiety

Indication

Mood Disorders

Indication

Post-Traumatic Stress Disorder

Product

Rectal swab