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Assisted Animal Therapy: ReAnimal (ReAnimal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898843
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date September 17, 2020
Estimated Study Start Date  ICMJE October 31, 2020
Estimated Primary Completion Date August 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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.
  • Patient Satisfaction score [ Time Frame: 2 days after inclusion, at the end of AAT session ]
    Only for AAT group
  • Patient Satisfaction score [ Time Frame: 90 days after AAT session ]
    Only for AAT group
  • Caregiver Satisfaction score [ Time Frame: 2 days after inclusion, at the end of AAT session ]
  • Caregiver Satisfaction score [ Time Frame: 90 days after AAT or sham session ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assisted Animal Therapy: ReAnimal
Official Title  ICMJE Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Anxiety
  • Mood Disorders
  • Post Traumatic Stress Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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)
    • Biological: Rectal swab sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2022
Estimated Primary Completion Date August 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898843
Other Study ID Numbers  ICMJE 69HCL18_0804
2018-A02789-46 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amélie MAZAUD, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP