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临床试验/NCT03304769
NCT03304769Unknown不适用

Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2017年9月28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
116
试验地点
1
主要终点
Successful IV placement with first attempt

研究概览

简要总结

This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.

详细描述

Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10

This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.

研究设计

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

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patient aged 4-17 years
  • •Requiring IV placement
  • •Child Life unavailable

排除标准

  • •Previous enrollment in the study
  • •Physically/ developmentally unable to tolerate headset
  • •Skin/eye pathology
  • •Critically ill patient
  • •Language other than English or Spanish
  • •Student Nurse placing IV

研究组 & 干预措施

IV placement no Virtual reality

No Intervention

Patient will have IV placed in traditional manner, with no virtual reality headset

IV placement with Virtual Reality

Experimental

Patient will have IV placed with Virtual Reality headset distraction

干预措施: Virtual Reality (Device)

结局指标

主要结局

Successful IV placement with first attempt

时间窗: 6 months

success in first attempt in VR group vs non VR group

次要结局

  • age range of patients that tolerate VR(6 months)
  • number of attempts before successfully establishing IV(6 months)
  • time to establishing successful IV(6 months)
  • Pre vs Post FACES revised pain scale parents(6 months)
  • Pre vs Post FACES revised pain Scale patients(6 months)
  • Pre vs Post Likert-Type Anxiety Scale - parents(6 months)
  • Pre vs Post Likert-Type Anxiety Scale- patients(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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