Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2020-09-18
2022-08-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Animal assisted therapy group
Patients included in this arm will have animal assisted therapy session in a specific room outside of the ICU. They will also have blood sampling for multidrug resistant bacteria screening and will answer to questionnaires
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.
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
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.
physiological parameters measure
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Visual Analog Scale (VAS)
Before and after AAT or sham session, pain will be evaluated thanks to VAS
Impact of Event Scale - Revised (IES-R)
Patients will answer IES-R questionnaire 3 months after AAT or sham session
satisfaction questionnaire
Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
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
Control Group
Patients included in this arm will have a "sham session" : they will leave their hospital bedroom, to go in the AAT session room. There, no specific activity is planned. After 20 minutes, the patient will go back to his room. They will also have blood sampling for multidrug resistant bacteria screening and will answer to questionnaires
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
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.
physiological parameters measure
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Visual Analog Scale (VAS)
Before and after AAT or sham session, pain will be evaluated thanks to VAS
Impact of Event Scale - Revised (IES-R)
Patients will answer IES-R questionnaire 3 months after AAT or sham session
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
Interventions
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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.
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
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.
physiological parameters measure
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Visual Analog Scale (VAS)
Before and after AAT or sham session, pain will be evaluated thanks to VAS
Impact of Event Scale - Revised (IES-R)
Patients will answer IES-R questionnaire 3 months after AAT or sham session
satisfaction questionnaire
Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
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
Eligibility Criteria
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Inclusion Criteria
* adult patient
* able to receive information and to give consent,
* with national social insurance
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Guillaume PETIT, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital Edouard Herriot - Anesthesiology department
Lyon, , France
Countries
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Other Identifiers
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2018-A02789-46
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0804
Identifier Type: -
Identifier Source: org_study_id
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