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临床试验/NCT07159568
NCT07159568尚未招募不适用

Visits by Pet Dogs to Patients Admitted to Intensive Care at the Clermont-Ferrand University Hospital: Feasibility Study

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
Success of the pet dog visit

研究概览

简要总结

Intensive Care Units (ICUs) are well known for their therapeutic and environmental aggressiveness. Current recommendations for the management of critically ill patients, including the "ABCDEF bundle," emphasize family engagement and liberal visitation policies for relatives and loved ones, with the aim of improving patient well-being during their ICU stay.

In France, half of all households own a pet. This close relationship between humans and animals explains why animals have long been involved in medical care. The earliest known use of animals in medicine dates back to the 9th century in Belgium, where they were used to assist individuals with mental illness. More recently, companion animal-assisted interventions have attracted growing interest due to their potential diagnostic and/or therapeutic value, as they may enhance the patient experience during hospitalization. The feasibility, safety, and potential benefits of pet visitation policies have mainly been assessed in conventional hospital wards, but remain understudied in the ICU setting. In France, to our knowledge, only three hospitals have allowed pet visits in the ICU, and these occurred outside of any research protocol.

The study primary objective is to assess the feasibility of companion dog visits in three medical-surgical ICUs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Adult patient aged 18 years or older,
  • Admitted to one of the participating ICUs at Clermont-Ferrand University Hospital (Estaing Adult ICU, Montpied Medical-Surgical ICU, or Montpied Neuro-ICU) with an expected ICU stay of 48 hours or more,
  • Owner of a companion dog, with family members or relatives able to bring the dog to the ICU.

排除标准

  • Patient-related exclusion criteria:
  • Refusal by the patient or by their family/relatives to participate,
  • Lack of affiliation with the French national health insurance system (Sécurité Sociale),
  • Patient deprived of liberty or under legal protection (guardianship, curatorship, or judicial safeguard),
  • Pregnant or breastfeeding patient,
  • Agitated patient, defined as a Richmond Agitation-Sedation Scale (RASS) score > 0 (monitored every four hours according to current standard practice),
  • Patient with immunosuppression, defined as: blood neutrophil count < 0.5 G/L, ongoing or recent (within the past month) treatment for solid or hematologic cancer (e.g., chemotherapy, radiotherapy, cell therapy), or receiving immunosuppressive drugs (including organ transplant recipients or corticosteroid therapy for more than two weeks),
  • Patient with known colonization by multidrug-resistant bacteria (as routinely assessed upon ICU admission and weekly thereafter),
  • Patient with one or more open wounds or injuries that cannot be covered with a dressing.
  • Dog-related exclusion criteria:
  • Dog belonging to category 1 or 2 breeds considered dangerous under current French regulations,
  • Dog that never leaves the home environment,
  • Dog with an incomplete vaccination status,
  • Dog with a known transmissible disease.

结局指标

主要结局

Success of the pet dog visit

时间窗: Immediately after the intervention

The success of the pet dog visit is defined as the entry of the animal into the patient's ICU room under the conditions specified in the study protocol

次要结局

  • Patient-related safety events regarding inconvenience or harm(Immediately after the intervention)
  • Patient-related safety events regarding infections(ICU discharge (within a maximum of 28 days))
  • Dog-related events regarding aggression or behavioral issues(Immediately after the intervention)
  • Staff-related events regarding inconvenience or harm(Immediately after the intervention)
  • Visit conditions in the case of success (excluding the safety criteria listed above)(Immediately after the intervention)
  • Reasons for potential visit failure (defined as the inability to bring the animal into the patient's ICU room)(Immediately before the intervention)
  • Pre-visit ICU staff satisfaction-related survey(Immediately before the intervention)
  • Post-visit ICU staff satisfaction-related survey(Immediately after the intervention)
  • Post-visit satisfaction survey of the patient's relative(s) who accompanied the dog(Immediately after the intervention)
  • Patient satisfaction survey(ICU discharge (within a maximum of 28 days))

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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