Assisted Animal Therapy: ReAnimal

Anxiety Clinical Trial

— ReAnimal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03898843
• Other study ID #: 69HCL18_0804
• Secondary ID: 2018-A02789-46
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: August 24, 2022

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Disease
• Mood Disorders
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 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.

Biological:
• 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

Behavioral:
• 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.

Procedure:
• physiological parameters measure
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.

Other:
• Visual Analog Scale (VAS)
Before and after AAT or sham session, pain will be evaluated thanks to VAS

Behavioral:
• 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

Biological:
• 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

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Anesthesiology department	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Satisfaction score	Only for AAT group	2 days after inclusion, at the end of AAT session
Secondary	Patient Satisfaction score	Only for AAT group	90 days after AAT session
Secondary	Caregiver Satisfaction score		2 days after inclusion, at the end of AAT session
Secondary	Caregiver Satisfaction score		90 days after AAT or sham session