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临床试验/NCT03518346
NCT03518346已完成不适用

Use of Virtual Reality Game Playing During Venipuncture

University of California, Davis2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年4月9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
12
试验地点
2
主要终点
Attempting vs. Refusing Venipuncture

研究概览

简要总结

To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.

详细描述

Participants will be randomly assigned using a random number generator to either the virtual reality condition, or to the standard procedure that includes using books and/or watching movies as a standard method of distraction.

Participants will take part in the study during their scheduled research venipuncture. The venipuncture lasts approximately 15-30 minutes. Pre and post venipuncture questionnaires for both participant and parent will take 15 minutes to complete. Total study time is between 30 and 45 minutes. Questionnaires completed by research personal will take 15 minutes to complete.

研究设计

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

入排标准

年龄范围
8 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 8-19 years old that are receiving a blood draw as part of their ReCHARGE evaluation
  • History of distress or refusal of blood draws or similar medical procedures OR
  • Parent or child endorsement of fear, anxiety, concern or adherence in past blood draw during the recruitment phone call, consent or child evaluation will be offered the potential of the VR intervention OR
  • Endorsement of anxiety or concerns with medical procedures on an in house phlebotomist blood draw screening form will also be used as inclusion criteria.

排除标准

  • History of seizures.
  • Vision loss or significant visual impairment to the degree that the participant is unable to see the activity and features of the VR game.

结局指标

主要结局

Attempting vs. Refusing Venipuncture

时间窗: 2 years

Compare if the participant is willing to let us attempt the venipuncture or refuses the venipuncture. the number of patients will be counted.

次要结局

  • Satisfaction Survey(2 years. Collected once on each participant: immediately following injection)
  • Pain Scale(2 years. Collected once on each participant: immediately following injection)
  • Time to Achieve Optimal Blood Volume(2 years. Collected on each participant: during venipuncture procedure)
  • Blood volume(2 years. Collected once on each participant: immediately following injection)
  • Fear Scale(2 years. Collected twice on each participant: before and immediately following injection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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