NCT03898843

Assisted Animal Therapy: ReAnimal

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety
• Mood Disorders
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-18
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2019-04-02
• Last updated: 2023-05-26

Locations

1 site across 1 country: France