AnxietyReAnimalNCT03898843
Assisted Animal Therapy: ReAnimal
A study testing Animal assisted therapy, Nasal swab sampling and STAI-Y and POMS Questionnaires in people with Anxiety and Mood Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Mood Disorders, Post Traumatic Stress Disorder
- What is being tested?
- Animal assisted therapy, Nasal swab sampling and STAI-Y and POMS Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
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.
- Conditions
- Anxiety, Mood Disorders, Post Traumatic Stress Disorder
- Being tested
- Animal assisted therapy, Nasal swab sampling, STAI-Y and POMS Questionnaires, physiological parameters measure, Visual Analog Scale (VAS)
- Keywords
- Animal assisted therapy, Intensive Care Unit, Anxiety
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal assisted therapyOther
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.
Nasal swab samplingBiological
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
STAI-Y and POMS QuestionnairesBehavioural
Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.
physiological parameters measureProcedure or surgery
Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
Visual Analog Scale (VAS)Other
Before and after AAT or sham session, pain will be evaluated thanks to VAS
Impact of Event Scale - Revised (IES-R)Behavioural
Patients will answer IES-R questionnaire 3 months after AAT or sham session
satisfaction questionnaireBehavioural
Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
Rectal swab samplingBiological
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 group | Role | What they receive |
|---|---|---|
| Animal assisted therapy group | Experimental | 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 Receives: 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 |
| Control Group | Active comparator | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before randomization
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.
Measured: 2 days after inclusion, before AAT or sham session
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.
Measured: 2 days after inclusion, after AAT or sham session
Secondary outcomes (17)
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.
Measured: 2 days after inclusion, before AAT or sham session
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.
Measured: 2 days after inclusion, after AAT or sham 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.
Measured: 2 days after inclusion, before AAT or sham 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.
Measured: 2 days after inclusion, after AAT or sham 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.
Measured: 2 days after inclusion, before AAT or sham 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.
Measured: 2 days after inclusion, after AAT or sham 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.
Measured: 2 days after inclusion, before AAT or sham 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.
Measured: 2 days after inclusion, after AAT or sham session
Visual Analog Scale (VAS) score
Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level
Measured: 2 days after inclusion, before AAT or sham session
Visual Analog Scale (VAS) score
Pain scale, from 0 = no pain at all, up to 10 = pain at maximum level
Measured: 2 days after inclusion, after AAT or sham session
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
Measured: At inclusion
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
Measured: 7 days after AAT or sham session
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.
Measured: 90 days after AAT or sham session
Patient Satisfaction score
Only for AAT group
Measured: 2 days after inclusion, at the end of AAT session
Patient Satisfaction score
Only for AAT group
Measured: 90 days after AAT session
Caregiver Satisfaction score
Measured: 2 days after inclusion, at the end of AAT session
Caregiver Satisfaction score
Measured: 90 days after AAT or sham session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start18 Sep 2020
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Why it stopped: Patient enrollment and logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume PETIT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898843
- Sponsor's protocol ID
- 69HCL18_0804
- Other IDs
- 2018-A02789-46
- Acronym
- ReAnimal
- Status last verified
- May 2023
- First submitted
- 27 Mar 2019
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
- ClinicalTrials.gov ID
- NCT03898843
- Acronym / sponsor ID
- ReAnimal / 69HCL18_0804
- Conditions
- Anxiety, Mood Disorders, Post Traumatic Stress Disorder
- Keywords
- Animal assisted therapy, Intensive Care Unit, Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrollment and logistical problems
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal assisted therapy group | Experimental | 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 samplingPatients 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 | Active comparator | 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 samplingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal assisted therapyPatients 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. | Other | Animal assisted therapy group |
| Nasal swab samplingAll patients will have nasal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria | Biological | Animal assisted therapy group, Control Group |
| STAI-Y and POMS QuestionnairesBefore and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires. | Behavioural | Animal assisted therapy group, Control Group |
| physiological parameters measureBefore and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured. | Procedure or surgery | Animal assisted therapy group, Control Group |
| Visual Analog Scale (VAS)Before and after AAT or sham session, pain will be evaluated thanks to VAS | Other | Animal assisted therapy group, Control Group |
| Impact of Event Scale - Revised (IES-R)Patients will answer IES-R questionnaire 3 months after AAT or sham session | Behavioural | Animal assisted therapy group, Control Group |
| satisfaction questionnairePatients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT | Behavioural | Animal assisted therapy group |
| Rectal swab samplingAll patients will have rectal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria | Biological | Animal assisted therapy group, Control Group |
Primary outcome
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.
17 secondary outcomes
Profile Of Mood States (POMS) score
Time frame: 2 days after inclusion, before AAT or sham session
Profile Of Mood States (POMS) score
Time frame: 2 days after inclusion, after AAT or sham session
Blood pressure
Time frame: 2 days after inclusion, before AAT or sham session
Blood pressure
Time frame: 2 days after inclusion, after AAT or sham session
Heart rate
Time frame: 2 days after inclusion, before AAT or sham session
Heart rate
Time frame: 2 days after inclusion, after AAT or sham session
Respiratory rate
Time frame: 2 days after inclusion, before AAT or sham session
Respiratory rate
Time frame: 2 days after inclusion, after AAT or sham session
Visual Analog Scale (VAS) score
Time frame: 2 days after inclusion, before AAT or sham session
Visual Analog Scale (VAS) score
Time frame: 2 days after inclusion, after AAT or sham session
Presence of Multi-drug resistant bacteria
Time frame: At inclusion
Presence of Multi-drug resistant bacteria
Time frame: 7 days after AAT or sham session
Impact of Event Scale - Revised (IES-R) score
Time frame: 90 days after AAT or sham session
Patient Satisfaction score
Time frame: 2 days after inclusion, at the end of AAT session
Patient Satisfaction score
Time frame: 90 days after AAT session
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
Results and safety
The study was stopped early (reason given: Patient enrollment and logistical problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume PETIT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal assisted therapy, Nasal swab sampling and STAI-Y and POMS Questionnaires in people with Anxiety and Mood Disorders, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient enrollment and logistical problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory Y (STAI-Y) score (time frame: Before randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.