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Assisted Animal Therapy: ReAnimal (ReAnimal)

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ClinicalTrials.gov Identifier: NCT03898843
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anxiety Mood Disorders Post Traumatic Stress Disorder Other: Animal assisted therapy Biological: Nasal swab sampling Behavioral: STAI-Y and POMS Questionnaires Procedure: physiological parameters measure Other: Visual Analog Scale (VAS) Behavioral: Impact of Event Scale - Revised (IES-R) Behavioral: satisfaction questionnaire Biological: Rectal swab sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Animal assisted therapy group
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
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

Active Comparator: Control Group
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
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

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




Primary Outcome Measures :
  1. State-Trait Anxiety Inventory Y (STAI-Y) score [ Time Frame: Before randomization ]
    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.

  2. State-Trait Anxiety Inventory Y (STAI-Y) score [ Time Frame: 2 days after inclusion, before 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.

  3. State-Trait Anxiety Inventory Y (STAI-Y) score [ Time Frame: 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 :
  1. Profile Of Mood States (POMS) score [ Time Frame: 2 days after inclusion, before 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.

  2. Profile Of Mood States (POMS) score [ Time Frame: 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.

  3. Blood pressure [ Time Frame: 2 days after inclusion, before 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.

  4. Blood pressure [ Time Frame: 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.

  5. Heart rate [ Time Frame: 2 days after inclusion, before 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.

  6. Heart rate [ Time Frame: 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.

  7. Respiratory rate [ Time Frame: 2 days after inclusion, before 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.

  8. Respiratory rate [ Time Frame: 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.

  9. Visual Analog Scale (VAS) score [ Time Frame: 2 days after inclusion, before AAT or sham session ]
    Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level

  10. Visual Analog Scale (VAS) score [ Time Frame: 2 days after inclusion, after AAT or sham session ]
    Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level

  11. Presence of Multi-drug resistant bacteria [ Time Frame: At inclusion ]
    Nasal and rectal sampling, looking for methicillin resistant staphylococcus aureus in nasal sampling, and multi-drug resistant bacteria in rectal sampling

  12. Presence of Multi-drug resistant bacteria [ Time Frame: 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

  13. Impact of Event Scale - Revised (IES-R) score [ Time Frame: 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.

  14. Patient Satisfaction score [ Time Frame: 2 days after inclusion, at the end of AAT session ]
    Only for AAT group

  15. Patient Satisfaction score [ Time Frame: 90 days after AAT session ]
    Only for AAT group

  16. Caregiver Satisfaction score [ Time Frame: 2 days after inclusion, at the end of AAT session ]
  17. Caregiver Satisfaction score [ Time Frame: 90 days after AAT or sham session ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898843


Contacts
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Contact: Amélie MAZAUD, MD 47212320 ext +33 Amelie.mazaud@chu-lyon.fr
Contact: Valérie CERRO, CRA +33 4.72.11.69.86 valerie.cerro01@chu-lyon.fr

Locations
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France
Hôpital Edouard Herriot - Anesthesiology department Not yet recruiting
Lyon, France, 69003
Contact: Amélie MAZAUD, MD, PhD    +3347212320    amelie.mazaud@chu-lyon.fr   
Contact: Valérie CERRO, CRA    +33 4.72.11.69.86    valerie.cerro01@chu-lyon.fr   
Principal Investigator: Amélie MAZAUD, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Amélie MAZAUD, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03898843     History of Changes
Other Study ID Numbers: 69HCL18_0804
2018-A02789-46 ( Other Identifier: ID-RCB )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Animal assisted therapy
Intensive Care Unit
Anxiety

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Mood Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders