Anxiety, Mood Disorders, Post Traumatic Stress Disorder
Conditions
Keywords
Animal assisted therapy, Intensive Care Unit, Anxiety
Brief summary
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.
Interventions
OTHERAnimal 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.
BIOLOGICALNasal 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
BEHAVIORALSTAI-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.
PROCEDUREphysiological parameters measure
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Before and after AAT or sham session, pain will be evaluated thanks to VAS
BEHAVIORALImpact of Event Scale - Revised (IES-R)
Patients will answer IES-R questionnaire 3 months after AAT or sham session
BEHAVIORALsatisfaction questionnaire
Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
BIOLOGICALRectal 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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory Y (STAI-Y) score | Before randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 2 days after inclusion, before AAT or sham session | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. |
| Heart rate | 2 days after inclusion, before AAT or sham session | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. |
| Respiratory rate | 2 days after inclusion, before AAT or sham session | Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session. |
| Visual Analog Scale (VAS) score | 2 days after inclusion, before AAT or sham session | Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level |
| Profile Of Mood States (POMS) score | 2 days after inclusion, before AAT or sham session | 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. |
| Impact of Event Scale - Revised (IES-R) score | 90 days after AAT or sham session | 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. |
| Patient Satisfaction score | 2 days after inclusion, at the end of AAT session | Only for AAT group |
| Caregiver Satisfaction score | 2 days after inclusion, at the end of AAT session | — |
| Presence of Multi-drug resistant bacteria | At inclusion | Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling |
Countries
France
Outcome results
None listed