Assisted Animal Therapy: ReAnimal

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Mood Disorders, Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Animal assisted therapy
* Biological: Nasal swab sampling
* Behavioral: STAI-Y and POMS Questionnaires
* Procedure: physiological parameters measure
* Other: Visual Analog Scale (VAS)
* Behavioral: Impact of Event Scale - Revised (IES-R)
* Behavioral: satisfaction questionnaire
* Biological: Rectal swab sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal assisted therapy group<br>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 | Other: Animal assisted therapy<br>* 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.<br>Biological: Nasal swab sampling<br>* 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<br>Behavioral: STAI-Y and POMS Questionnaires<br>* Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.<br>Procedure: physiological parameters measure<br>* Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.<br>Other: Visual Analog Scale (VAS)<br>* Before and after AAT or sham session, pain will be evaluated thanks to VAS<br>Behavioral: Impact of Event Scale - Revised (IES-R)<br>* Patients will answer IES-R questionnaire 3 months after AAT or sham session<br>Behavioral: satisfaction questionnaire<br>* Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT<br>Biological: Rectal swab sampling<br>* 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<br>|
| Active Comparator: Control Group<br>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 | Biological: Nasal swab sampling<br>* 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<br>Behavioral: STAI-Y and POMS Questionnaires<br>* Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.<br>Procedure: physiological parameters measure<br>* Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.<br>Other: Visual Analog Scale (VAS)<br>* Before and after AAT or sham session, pain will be evaluated thanks to VAS<br>Behavioral: Impact of Event Scale - Revised (IES-R)<br>* Patients will answer IES-R questionnaire 3 months after AAT or sham session<br>Biological: Rectal swab sampling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory Y (STAI-Y) score | Self-administered questionnaire, of 20 questions whose answers are either No, Rather no Rather yes Yes. Points calculated are 1 point for each No answer, up to 4 points for each Yes answer. Thus, score can be at least 20 points, at most 80 points. | Before randomization | 
| State-Trait Anxiety Inventory Y (STAI-Y) score | Self-administered questionnaire, of 20 questions whose answers are either No, Rather no Rather yes Yes. Points calculated are 1 point for each No answer, up to 4 points for each Yes answer. Thus, score can be at least 20 points, at most 80 points. | 2 days after inclusion, before AAT or sham session | 
| State-Trait Anxiety Inventory Y (STAI-Y) score | Self-administered questionnaire, of 20 questions whose answers are either No, Rather no Rather yes Yes. Points calculated are 1 point for each No answer, up to 4 points for each Yes answer. Thus, score can be at least 20 points, at most 80 points. | 2 days after inclusion, after AAT or sham session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile Of Mood States (POMS) score | Self-administered questionnaire, of 37 questions, whose answers are either not at all, a little, moderately, quite a lot, or extremely. Each adjective in the POMS questionnaire is awarded the following score: 0 - Not at all 1 - A little 2 - Moderately 3 - Quite a Lot 4 - Extremely except Relaxed and Efficient and they score the reverse: 4 - Not at all 3 - A little 2 - Moderately 1 - Quite a Lot 0 - Extremely Thus, the score can range from 0 up to 148 points. | 2 days after inclusion, before AAT or sham session | 
| Profile Of Mood States (POMS) score | Self-administered questionnaire, of 37 questions, whose answers are either not at all, a little, moderately, quite a lot, or extremely. Each adjective in the POMS questionnaire is awarded the following score: 0 - Not at all 1 - A little 2 - Moderately 3 - Quite a Lot 4 - Extremely except Relaxed and Efficient and they score the reverse: 4 - Not at all 3 - A little 2 - Moderately 1 - Quite a Lot 0 - Extremely Thus, the score can range from 0 up to 148 points. | 2 days after inclusion, after AAT or sham session | 
| Blood pressure | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, before AAT or sham session | 
| Blood pressure | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, after AAT or sham session | 
| Heart rate | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, before AAT or sham session | 
| Heart rate | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, after AAT or sham session | 
| Respiratory rate | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, before AAT or sham session | 
| Respiratory rate | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. | 2 days after inclusion, after AAT or sham session | 
| Visual Analog Scale (VAS) score | Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level | 2 days after inclusion, before AAT or sham session | 
| Visual Analog Scale (VAS) score | Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level | 2 days after inclusion, after AAT or sham session | 
| Presence of Multi-drug resistant bacteria | Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling | At inclusion | 
| Presence of Multi-drug resistant bacteria | Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling | 7 days after AAT or sham session | 
| Impact of Event Scale - Revised (IES-R) score | Score for post traumatic stress disease. 22 questions self administered, whose answers are either not at all, a little, moderately, quite a lot, or extremely. Each question is awarded score from 0 (not at all) up to 4 (extremely). Thus, the total score ranges from 0 up to 88 points. | 90 days after AAT or sham session | 
| Patient Satisfaction score | Only for AAT group | 2 days after inclusion, at the end of AAT session | 
| Patient Satisfaction score | Only for AAT group | 90 days after AAT session | 
| Caregiver Satisfaction score |  | 2 days after inclusion, at the end of AAT session | 
| Caregiver Satisfaction score |  | 90 days after AAT or sham session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Animal assisted therapy, Intensive Care Unit, Anxiety