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Assisted Animal Therapy: ReAnimal (ReAnimal)

Primary Purpose

Anxiety, Mood Disorders, Post Traumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Animal assisted therapy
Nasal swab sampling
STAI-Y and POMS Questionnaires
physiological parameters measure
Visual Analog Scale (VAS)
Impact of Event Scale - Revised (IES-R)
satisfaction questionnaire
Rectal swab sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Animal assisted therapy, Intensive Care Unit, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital Edouard Herriot - Anesthesiology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Animal assisted therapy group

Control Group

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2019
Last Updated
May 25, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03898843
Brief Title
Assisted Animal Therapy: ReAnimal
Acronym
ReAnimal
Official Title
Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Patient enrollment and logistical problems
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Mood Disorders, Post Traumatic Stress Disorder
Keywords
Animal assisted therapy, Intensive Care Unit, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animal assisted therapy group
Arm Type
Experimental
Arm 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
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Animal assisted therapy
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Nasal swab sampling
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
STAI-Y and POMS Questionnaires
Intervention Description
Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.
Intervention Type
Procedure
Intervention Name(s)
physiological parameters measure
Intervention Description
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Intervention Type
Other
Intervention Name(s)
Visual Analog Scale (VAS)
Intervention Description
Before and after AAT or sham session, pain will be evaluated thanks to VAS
Intervention Type
Behavioral
Intervention Name(s)
Impact of Event Scale - Revised (IES-R)
Intervention Description
Patients will answer IES-R questionnaire 3 months after AAT or sham session
Intervention Type
Behavioral
Intervention Name(s)
satisfaction questionnaire
Intervention Description
Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
Intervention Type
Biological
Intervention Name(s)
Rectal swab sampling
Intervention Description
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
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory Y (STAI-Y) score
Description
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.
Time Frame
Before randomization
Title
State-Trait Anxiety Inventory Y (STAI-Y) score
Description
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.
Time Frame
2 days after inclusion, before AAT or sham session
Title
State-Trait Anxiety Inventory Y (STAI-Y) score
Description
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.
Time Frame
2 days after inclusion, after AAT or sham session
Secondary Outcome Measure Information:
Title
Profile Of Mood States (POMS) score
Description
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.
Time Frame
2 days after inclusion, before AAT or sham session
Title
Profile Of Mood States (POMS) score
Description
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.
Time Frame
2 days after inclusion, after AAT or sham session
Title
Blood pressure
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, before AAT or sham session
Title
Blood pressure
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, after AAT or sham session
Title
Heart rate
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, before AAT or sham session
Title
Heart rate
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, after AAT or sham session
Title
Respiratory rate
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, before AAT or sham session
Title
Respiratory rate
Description
Physiological parameters noted on the patient usual monitoring in Intensive Care Unit (ICU), which the patient will keep during the whole session.
Time Frame
2 days after inclusion, after AAT or sham session
Title
Visual Analog Scale (VAS) score
Description
Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level
Time Frame
2 days after inclusion, before AAT or sham session
Title
Visual Analog Scale (VAS) score
Description
Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level
Time Frame
2 days after inclusion, after AAT or sham session
Title
Presence of Multi-drug resistant bacteria
Description
Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling
Time Frame
At inclusion
Title
Presence of Multi-drug resistant bacteria
Description
Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling
Time Frame
7 days after AAT or sham session
Title
Impact of Event Scale - Revised (IES-R) score
Description
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.
Time Frame
90 days after AAT or sham session
Title
Patient Satisfaction score
Description
Only for AAT group
Time Frame
2 days after inclusion, at the end of AAT session
Title
Patient Satisfaction score
Description
Only for AAT group
Time Frame
90 days after AAT session
Title
Caregiver Satisfaction score
Time Frame
2 days after inclusion, at the end of AAT session
Title
Caregiver Satisfaction score
Time Frame
90 days after AAT or sham session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume PETIT, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot - Anesthesiology department
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Learn more about this trial

Assisted Animal Therapy: ReAnimal

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