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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02789-46 | Other Identifier | ID-RCB |
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Patient enrollment and logistical problems
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Animal assisted therapy group | Experimental | 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 |
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| Control Group | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal assisted therapy | Other | 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. |
| 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 |
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume PETIT, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot - Anesthesiology department | Lyon | 69003 | France |
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| Nasal swab sampling | Biological | 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 |
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| STAI-Y and POMS Questionnaires | Behavioral | Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires. |
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| physiological parameters measure | Procedure | Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured. |
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| Visual Analog Scale (VAS) | Other | Before and after AAT or sham session, pain will be evaluated thanks to VAS |
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| Impact of Event Scale - Revised (IES-R) | Behavioral | Patients will answer IES-R questionnaire 3 months after AAT or sham session |
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| satisfaction questionnaire | Behavioral | Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT |
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| Rectal swab sampling | Biological | 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 |
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| 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:
| 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D056447 | Animal Assisted Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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