Assisted Animal Therapy: ReAnimal

Not Applicable

Terminated

• Conditions: Anxiety; Post Traumatic Stress Disorder; Mood Disorders
• Interventions: Other: Animal assisted therapy; Biological: Nasal swab sampling; Procedure: physiological parameters measure; Behavioral: STAI-Y and POMS Questionnaires; Other: Visual Analog Scale (VAS); Behavioral: Impact of Event Scale - Revised (IES-R); Behavioral: satisfaction questionnaire; Biological: Rectal swab sampling

• Registration Number: NCT03898843
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2020-09-18
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	physiological parameters measure	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
Control Group	Visual Analog Scale (VAS)	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
Animal assisted therapy group	STAI-Y and POMS Questionnaires	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
Animal assisted therapy group	physiological parameters measure	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
Animal assisted therapy group	Impact of Event Scale - Revised (IES-R)	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
Animal assisted therapy group	Rectal swab sampling	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
Control Group	STAI-Y and POMS Questionnaires	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
Animal assisted therapy group	Animal assisted therapy	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
Control Group	Nasal swab sampling	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
Control Group	Impact of Event Scale - Revised (IES-R)	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
Animal assisted therapy group	Visual Analog Scale (VAS)	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
Animal assisted therapy group	Nasal swab sampling	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
Animal assisted therapy group	satisfaction questionnaire	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
Control Group	Rectal swab sampling	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

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory Y (STAI-Y) score	2 days after inclusion, after AAT or sham session	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.

Secondary Outcome Measures

Name	Time	Method
Profile Of Mood States (POMS) score	2 days after inclusion, after AAT or sham session	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.
Presence of Multi-drug resistant bacteria	7 days after AAT or sham session	Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling
Heart rate	2 days after inclusion, after AAT or sham session	Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Respiratory rate	2 days after inclusion, after AAT or sham session	Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Patient Satisfaction score	90 days after AAT session	Only for AAT group
Visual Analog Scale (VAS) score	2 days after inclusion, after AAT or sham session	Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level
Caregiver Satisfaction score	90 days after AAT or sham session
Blood pressure	2 days after inclusion, after AAT or sham session	Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Impact of Event Scale - Revised (IES-R) score	90 days after AAT or sham session	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.

Trial Locations

Locations (1)

Hôpital Edouard Herriot - Anesthesiology department; 🇫🇷 Lyon, France