Assisted Animal Therapy: ReAnimal (ReAnimal)

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

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.

Study Overview

• Status: Terminated
• Conditions: Mood Disorders; Anxiety; Post Traumatic Stress Disorder
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hôpital Edouard Herriot - Anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Behavioral: 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
Active Comparator: 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	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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Guillaume PETIT, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Intensive Care Unit; Animal assisted therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mood Disorders
• Other Study ID Numbers: 69HCL18_0804; 2018-A02789-46 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No