跳至主要内容
临床试验/NCT04491149
NCT04491149Unknown不适用

The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Anxiety level

研究概览

简要总结

Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.

The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women undergoing amniocentesis/foeticide who will sign an informed consent form

排除标准

  • •Women younger than 18 years
  • •Twin pregnancies
  • •Women with vertigo

研究组 & 干预措施

women using virtual glass during amniocentesis/foeticide

Experimental

干预措施: virtual reality glasses (Device)

women undergoing amniocentesis/foeticide

No Intervention

结局指标

主要结局

Anxiety level

时间窗: Up to one hour after the procedure

Spielberger's State-Trait Anxiety Inventory

Anxiety level

时间窗: Up to one hour before the procedure

Spielberger's State-Trait Anxiety Inventory

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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