跳至主要内容
临床试验/NCT04558086
NCT04558086已完成不适用

The Effects of Using an Interactive Game With Virtual Reality to Reduce the Pain and Fear for Children During an Intravenous Placement

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2020年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
The degrees of pain experienced by the children.

研究概览

简要总结

To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Children ages 6-
  • Children who where clearly conscious.
  • Children who agreed and were required to receive intravenous injections after physicians' diagnoses.
  • Children and their primary caregivers who could communicate in Mandarin or Taiwanese
  • Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

排除标准

  • Children with developmental delay, epilepsy, or heart diseases
  • Children undergoing chemotherapy; children who were visually or hearing impaired
  • Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters.
  • Children who had sustained head trauma in the past month
  • Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
  • Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
  • Children who received two or more intravenous injections and had their blood drawn only one time

结局指标

主要结局

The degrees of pain experienced by the children.

时间窗: The posttests 8 min after the tourniquets were worn.

Measurement of pin using the Wong-Baker Faces Pain Rating Scale (WBFPS). The scale contains six cartoon faces shwing pain ratings of 0\~10, which are, from left to right, no pain(0), a little pain (2), mild pain (4), average pain (6), severe pain (8), and excruciating pain (10).The children, primary caregivers, and nurses were asked to select the faces that best described the pain levels experienced by the children receiving intravenous injections; the pain levels were subsequently converted into numerical values .

The degrees of fear experienced by the children.

时间窗: The posttests 8 min after the tourniquets were worn.

Measurement of fear using the Choldren Fear Scale(CFS).The scale consists of five cartoon faces showing fear ratings of 0-4, which were no fear (0), a little fear (1), some fear (2), very fear(3) and extreme fear (4). The children, primary caregivers, and nurses were asked to select the faces that best described the fear levels of the children receiving intravenous injections. The pain levels were subsequently converted into numerical values.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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