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临床试验/NCT02665403
NCT02665403已完成不适用

Play Interventions to Reduce Anxiety and Negative Emotions in Hospitalized Children

The University of Hong Kong0 个研究点目标入组 304 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
304
主要终点
Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7

研究概览

简要总结

Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children. Hospital play interventions have been widely used to prepare children for invasive medical procedures and hospitalization. Nevertheless, there is an imperative need for rigorous empirical scrutiny of the effectiveness of hospital play interventions, in particular, using play activities to ease the psychological burden of hospitalized children. This study tested the effectiveness of play interventions to reduce anxiety and negative emotions in hospitalized children. A non-equivalent control group pre-test and post-test, between subjects design was conducted in the two largest acute-care public hospitals in Hong Kong. A total of 304 Chinese children (ages 3-12) admitted for treatments in these two hospitals were invited to participate in the study. Of the 304 paediatric patients, 154 received hospital play interventions and 150 received usual care.

详细描述

This study tested the effectiveness of play interventions to reduce anxiety and negative emotions in hospitalized children.

Intervention

Placebo control group

In the control group, children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management.

Experimental group

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • were Chinese children aged between 3 and 12,
  • able to speak Cantonese
  • required to stay in hospital for at least three consecutive days

排除标准

  • children with identified cognitive and learning difficulties

结局指标

主要结局

Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 3 - 7

时间窗: two days after admission

Anxiety levels of children aged between 3 and 7 were assessed by using the Visual Analogue Scale , which consists of a 10 cm horizontal line on a piece of card, with different facial expressions supplemented by the words 'I have no anxiety' at one end and 'I have so much anxiety' at the other. They were asked to respond to this scale at 2 days after admission.

次要结局

  • baseline anxiety levels for children aged 3 - 7(baseline)
  • Anxiety levels change from baseline at 2 days after admission between intervention and control group for children aged 8 - 12(two days after admission)
  • baseline anxiety levels for children aged 8 -12(baseline)
  • overall emotion behaviors for the 2-day period of hospitalization (CEMS)(the 2-day period of hospitalization)

研究者

申办方类型
Other
责任方
Sponsor

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