Assisted Animal Therapy: ReAnimal

Civil Hospices of Lyon

Status: Terminated

Conditions: Post Traumatic Stress Disorder; Mood Disorders; Anxiety

Treatments: Biological: Rectal swab sampling; Behavioral: satisfaction questionnaire; Procedure: physiological parameters measure; Biological: Nasal swab sampling; Behavioral: STAI-Y and POMS Questionnaires; Behavioral: Impact of Event Scale - Revised (IES-R); Other: Animal assisted therapy; Other: Visual Analog Scale (VAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03898843

69HCL18_0804

2018-A02789-46 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7 participants in 2 patient groups

Animal assisted therapy group

Experimental group

Description:

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

Treatment:

Other: Animal assisted therapy

Other: Visual Analog Scale (VAS)

Biological: Rectal swab sampling

Behavioral: satisfaction questionnaire

Procedure: physiological parameters measure

Biological: Nasal swab sampling

Behavioral: STAI-Y and POMS Questionnaires

Behavioral: Impact of Event Scale - Revised (IES-R)

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Visual Analog Scale (VAS)

Biological: Rectal swab sampling

Procedure: physiological parameters measure

Biological: Nasal swab sampling

Behavioral: STAI-Y and POMS Questionnaires

Behavioral: Impact of Event Scale - Revised (IES-R)