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临床试验/NCT05275621
NCT05275621Unknown不适用

Virtual Reality for Vascular Access: a Multicenter Feasibility Study

ASST Fatebenefratelli Sacco10 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
10
主要终点
Change in baseline Pain assessed by the Wong-Baker FACES Scale

研究概览

简要总结

In pediatric patients Peripherally Inserted Central Catheters (PICC) insertion requires pharmacological sedation provided by an anesthesiologist, which poses a certain degree of risks. In enrolled subjects, PICC insertion is tried without drug sedation, using an immersive virtual reality experience as a distraction technique. If the subjects is not able to keep still or if pain levels are too high, the virtual reality attempt is stopped and standard drug sedation is provided by a pediatric anesthesiologist.

Aim of study is to evaluate the feasibility of the PICC insertion procedure using the virtual reality distraction technique. The investigators hypothesize that this could avoid the need for drug sedation, reducing sedation-related risks and costs and reduce anxiety and pain related to the procedure.

详细描述

A PICC is a central intravenous catheter inserted through a peripheral vein of the upper arm. In pediatric subjects, the insertion usually requires pharmacological sedation because of the anxiety and the pain experienced by the children during the procedure. Sedation inevitably poses a certain risk, particularly of airway obstruction, respiratory drive reduction en hemodynamic instability. Finally, costs are sensibly higher when sedation is required, since, besides the need for drugs and devices (e.g. for monitoring and airway management), an experienced pediatric anesthesiologist and a nurse are needed for providing sedation.

The investigators hypothesize that the application of virtual reality to children undergoing PICC placement, could avoid the need for drug sedation. This would result in a reduction in anxiety and pain related to the procedure and a potential reduction in costs. Moreover any possible adverse event related to pharmacological sedation would be avoided.

The material used for providing the virtual reality experience consist of a commercially available virtual reality headset (Oculus Quest 2 by Facebook Technologies ltd) and a dedicated software called "TOMMI" (developed by Softcare Studios Srl). Subjects find themselves in a virtual environment where they can play different games. The game which was chosen is called "drums", optimized for enhanced sensorimotor engagement and distraction from acute sensations such as pain. In this game subjects see three different drums they can beat with a "magic wand" they can control by moving the handheld controller. Geometric shapes in different colors fall from above indicating which drum to beat and at which time.

This game was chosen for several reasons: it can be played for sufficient time without getting excessively boring or tiring (the procedure usually lasts about half an hour); it can be easily played both by younger and older children; it does not require wide movements either of the head or of the upper limb holding the controller, and the opposite upper limb isn't involved in any way. Thus, distracting or even dangerous movements of the subject can be avoided, ensuring the successful completion of the procedure.

Subjects will be enrolled by the investigators in each participating center according to the inclusion and exclusion criteria. To participate informed consent has to be acquired in written form from both the caregivers and, if able to do so, also by the subjects.

研究设计

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

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 7 and 14 years old
  • Indication for Vascular Access Device placement with the need for sedation
  • Signed informed consent form by the subject's caregivers (commonly both parents)

排除标准

  • Inability to fill in the rating scales
  • Inability to experience Virtual Reality with TOMMI (e.g., eye diseases)
  • Presence of disease that produces complete immobility
  • Refusal to sign informed consent

结局指标

主要结局

Change in baseline Pain assessed by the Wong-Baker FACES Scale

时间窗: Baseline and Five minutes after the procedure has been completed

The Wong-Baker FACES Scale is a validated scale used to assess the experienced pain in subjects from three years of age. It consists of six different faces: the first represents no pain at all and is described by the words "No Hurt" and the last one represents a pain score of "10 out of 10" on a numeric rating scale, and indicates "hurts worst."

Change in baseline Anxiety assessed by a numeric rating scale

时间窗: Baseline and Five minutes after the procedure has been completed

Anxiety is assessed through a numeric rating scale ranging from zero representing no anxiety at all, up to ten representing the worst anxiety level.

次要结局

  • Duration of the procedure(During the procedure)
  • Subject's satisfaction(through study completion, an average of three months)
  • Staff satisfaction(After study completion, expected six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Gemma

Director of Anesthesia and Intensive Care Unit

ASST Fatebenefratelli Sacco

研究点 (10)

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