Clinical trial NCT03898843: Assisted Animal Therapy: ReAnimal
Official title: Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Mood Disorders
Post Traumatic Stress Disorder
Keywords: Animal assisted therapy
Intensive Care Unit
Anxiety
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: State-Trait Anxiety Inventory Y (STAI-Y) score
timeFrame: Before randomization
measure: State-Trait Anxiety Inventory Y (STAI-Y) score
timeFrame: 2 days after inclusion, before AAT or sham session
measure: State-Trait Anxiety Inventory Y (STAI-Y) score
timeFrame: 2 days after inclusion, after AAT or sham session
Secondary outcomes:
measure: Profile Of Mood States (POMS) score
timeFrame: 2 days after inclusion, before AAT or sham session
measure: Profile Of Mood States (POMS) score
timeFrame: 2 days after inclusion, after AAT or sham session
measure: Blood pressure
timeFrame: 2 days after inclusion, before AAT or sham session
measure: Blood pressure
timeFrame: 2 days after inclusion, after AAT or sham session
measure: Heart rate
timeFrame: 2 days after inclusion, before AAT or sham session
measure: Heart rate
timeFrame: 2 days after inclusion, after AAT or sham session
measure: Respiratory rate
timeFrame: 2 days after inclusion, before AAT or sham session
measure: Respiratory rate
timeFrame: 2 days after inclusion, after AAT or sham session
measure: Visual Analog Scale (VAS) score
timeFrame: 2 days after inclusion, before AAT or sham session
measure: Visual Analog Scale (VAS) score
timeFrame: 2 days after inclusion, after AAT or sham session
measure: Presence of Multi-drug resistant bacteria
timeFrame: At inclusion
measure: Presence of Multi-drug resistant bacteria
timeFrame: 7 days after AAT or sham session
measure: Impact of Event Scale - Revised (IES-R) score
timeFrame: 90 days after AAT or sham session
measure: Patient Satisfaction score
timeFrame: 2 days after inclusion, at the end of AAT session
measure: Patient Satisfaction score
timeFrame: 90 days after AAT session
measure: Caregiver Satisfaction score
timeFrame: 2 days after inclusion, at the end of AAT session
measure: Caregiver Satisfaction score
timeFrame: 90 days after AAT or sham session
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Anesthesiology department
Study officials:
affiliation: Hospices Civils de Lyon
name: Guillaume PETIT, MD
role: PRINCIPAL_INVESTIGATOR
References: