跳至主要内容
临床试验/NCT06474702
NCT06474702尚未招募不适用

Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.

Sheba Medical Center0 个研究点目标入组 30 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
movements.

研究概览

简要总结

The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'Edmond and Lily Safra' Children's Hospital, Sheba Medical Centre, Tel Hashomer, Ramat Gan, Israel during 2024.

排除标准

  • the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during
  • additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.

结局指标

主要结局

movements.

时间窗: 12 months (july 2024-july 2025)

movements frequency of the patient, collected by the smart-watch using 3 axis-accelerometer that can detect movements in 3 dimensions. for example, number of steps taken.

physiological parameter

时间窗: 12 months (july 2024-july 2025)

sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)

次要结局

  • violence assessment with 'MOAS' score system.(12 months (july 2024-july 2025))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Prof. Doron Gothelf MD

head of child and adolescent psychiatry division

Sheba Medical Center

相似试验