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临床试验/NCT05892874
NCT05892874已完成不适用

Impact of Postoperative Medical Equipment Removal/insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

Claude Bernard University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
State Trait Anxiety Index - Y version

研究概览

简要总结

A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

详细描述

A lot of observationnal studies describe parental stressors in Paediatric Intensive care Unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal or insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via Visual Analog Stress Scale.

Parents will fill out questionnaire upon arrival in the Intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. Then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures

排除标准

  • Parents no french speaking
  • child hospitalized for Cardiac Catheterization
  • child hospitalized for Berlin Heart insertion
  • child hospitalized for heart transplantation

结局指标

主要结局

State Trait Anxiety Index - Y version

时间窗: at the arrival in the intensive care unit

Anxiety declarative scale from 20 to 80 maximum and higher anxiety

次要结局

  • Visual Analogic Scale(at the arrival in the intensive care unit)

研究者

发起方
Claude Bernard University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilot Marc

Director of research

Claude Bernard University

研究点 (1)

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