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临床试验/NCT04610281
NCT04610281已完成不适用

Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

Groupe Hospitalier de la Rochelle Ré Aunis1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Number of Crises

研究概览

简要总结

The objective is to compare the care including the solution of ambient sensory biofeedback "Inner Garden", compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. The nursing support with the "Inner Garden" tool in three care units will be compared with the practice in six other units not equipped with this tool.

详细描述

Psychiatric illnesses affect more than one person in five each year. In France, the majority of disorders among minors under the care of child psychiatry in full or part-time hospitalization are disorders of psychological development (32%) and behavioural and emotional disorders (24.6%). Hospitalisation is reserved for the most complex acute crisis situations, as well as for children who need to be cared for by a multidisciplinary team several times a week to support their psychological development. In our study, the investigators focus on one of the clinical manifestations regularly present: the state of agitation when its intensity is moderate to severe. "The state of agitation is defined as a psychic, motor and relational behavioural disorder that leads to a reaction of intolerance on the part of people in the entourage". The care teams will then implement care actions that will be a graduated response adapted to the intensity of these states of agitation. In addition to the support provided by a caregiver, the investigators propose to use the "Inner Garden" system developed in 2014 at the laboratory of National Institute for Research in Digital Science and Technology in Bordeaux. It is an interactive Zen garden allowing to present feedback (topographical, physiological) under different sensory modalities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Taken care in Children's Hospitalization Unit of Child Psychiatry Department,
  • •Parent affiliated or beneficiary of social security,
  • •Information to the child and the legal representative(s) and signed consent by the legal representative(s).

排除标准

  • •Refusal to participate on the part of the child and/or legal representative(s).

研究组 & 干预措施

Control

No Intervention

Wards without the "Inner Garden" biofeedback tool

Inner Garden

Experimental

Wards with the "Inner Garden" biofeedback tool

干预措施: Inner Garden (Device)

结局指标

主要结局

Number of Crises

时间窗: 8 months after inclusion

Agitation crises of moderate to severe intensity, which did not allow the child to reintegrate the group of care during the sessions A mild state of agitation does not require the child to be removed from the group and from the common place of care; A moderate agitation requires removal of the child from the group but not from the common place of care; In case of serious agitation, the child must be removed from the group and from the common care area to a "calming" room where the caregiver will take care of him/her individually.

次要结局

  • Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported(9 months after inclusion)
  • Score at the Emotion Regulation Checklist(8 months after inclusion)
  • Score at the Emotion Regulation Checklist(4 months after inclusion)

研究者

发起方
Groupe Hospitalier de la Rochelle Ré Aunis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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