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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable anxiety

Timeline

Completed

Started Sep 2020

Typical duration for not_applicable anxiety

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

March 27, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed

1.5 years until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed

Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

March 27, 2019

Last Update Submit

May 25, 2023

Conditions

Anxiety Mood Disorders Post Traumatic Stress Disorder

Keywords

Animal assisted therapyIntensive Care UnitAnxiety

Outcome Measures

Primary Outcomes (3)

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 Outcomes (17)

Profile Of Mood States (POMS) score
2 days after inclusion, before AAT or sham session
Profile Of Mood States (POMS) score
2 days after inclusion, after AAT or sham session
Blood pressure
2 days after inclusion, before AAT or sham session
Blood pressure
2 days after inclusion, after AAT or sham session
Heart rate
2 days after inclusion, before AAT or sham session
+12 more secondary outcomes

Study Arms (2)

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

Other: Animal assisted therapyBiological: Nasal swab samplingBehavioral: STAI-Y and POMS QuestionnairesProcedure: physiological parameters measureOther: Visual Analog Scale (VAS)Behavioral: Impact of Event Scale - Revised (IES-R)Behavioral: satisfaction questionnaireBiological: Rectal swab sampling

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

Biological: Nasal swab samplingBehavioral: STAI-Y and POMS QuestionnairesProcedure: physiological parameters measureOther: Visual Analog Scale (VAS)Behavioral: Impact of Event Scale - Revised (IES-R)Biological: Rectal swab sampling

Interventions

Animal assisted therapyOTHER

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.

Animal assisted therapy group

Nasal swab samplingBIOLOGICAL

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