Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory Y (STAI-Y) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Animal assisted therapy (Other)
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
干预措施: Nasal swab sampling (Biological)
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
干预措施: STAI-Y and POMS Questionnaires (Behavioral)
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
干预措施: physiological parameters measure (Procedure)
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
干预措施: Visual Analog Scale (VAS) (Other)
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
干预措施: Impact of Event Scale - Revised (IES-R) (Behavioral)
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
干预措施: satisfaction questionnaire (Behavioral)
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
干预措施: Rectal swab sampling (Biological)
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
干预措施: Nasal swab sampling (Biological)
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
干预措施: STAI-Y and POMS Questionnaires (Behavioral)
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
干预措施: physiological parameters measure (Procedure)
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
干预措施: Visual Analog Scale (VAS) (Other)
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
干预措施: Impact of Event Scale - Revised (IES-R) (Behavioral)
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
干预措施: Rectal swab sampling (Biological)
结局指标
主要结局
State-Trait Anxiety Inventory Y (STAI-Y) score
时间窗: 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.
State-Trait Anxiety Inventory Y (STAI-Y) score
时间窗: 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
时间窗: 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.
次要结局
- Profile Of Mood States (POMS) score(2 days after inclusion, after AAT or sham session)
- Presence of Multi-drug resistant bacteria(7 days after AAT or sham session)
- Heart rate(2 days after inclusion, after AAT or sham session)
- Respiratory rate(2 days after inclusion, after AAT or sham session)
- Patient Satisfaction score(90 days after AAT session)
- Visual Analog Scale (VAS) score(2 days after inclusion, after AAT or sham session)
- Caregiver Satisfaction score(90 days after AAT or sham session)
- Blood pressure(2 days after inclusion, after AAT or sham session)
- Impact of Event Scale - Revised (IES-R) score(90 days after AAT or sham session)
- Profile Of Mood States (POMS) score(2 days after inclusion, before AAT or sham session)
- Blood pressure(2 days after inclusion, before AAT or sham session)
- Heart rate(2 days after inclusion, before AAT or sham session)
- Respiratory rate(2 days after inclusion, before AAT or sham session)
- Visual Analog Scale (VAS) score(2 days after inclusion, before AAT or sham session)
- Presence of Multi-drug resistant bacteria(At inclusion)
- Patient Satisfaction score(2 days after inclusion, at the end of AAT session)
- Caregiver Satisfaction score(2 days after inclusion, at the end of AAT session)