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临床试验/NCT05378581
NCT05378581已完成不适用

Evaluation of the Use of a Virtual Reality Mask During Blood Tests and Prick Tests Performed in Allergic Children Aged 7 to 13 Years: a Multicenter, Randomized Trial

University Hospital, Clermont-Ferrand4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
4
主要终点
children's pain hetero-evaluation

研究概览

简要总结

Main objective :

Evaluate the effect of using a virtual reality mask during the blood test and pricks tests in allergic children aged from 7 to 13 years.

Hypothesis :

Using virtual reality mask during blood test and pricks tests for allergic kids from 7 to 13 would reduce anxiety and pain

详细描述

Investigation of food or respiratory allergy is based on prick tests and serum specific immunoglobulin E assays. The nurse often controls the blood test pain but during the skin tests, many children cry, feeling both fear and pain. This traumatic experience will in most cases be repeated during the child's allergic follow-up.

To date, there are few effective means of limiting anxiety and pain associated with prick tests and therefore little research work on this subject.

Immersion in virtual reality (VR) seems to be an interesting way of distraction for children from 7 to 13 years needing this treatment. Indeed, it makes it possible to saturate the sensorially of the child thus reducing the nociceptive perceptions and the anxiety. The choice of VR mask with pediatric program specific seems interesting for this children This is a randomized, open-label, two-armed parallel, multicenter therapeutic trial comparing an analgesic strategy using authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for allergics tests in children from 7 to 13 years old hospitalized in the pediatric consultation of Clermont Ferrand University Hospital and in the day hospital of Saint-Etienne University Hospital

The control arm is the local anesthetic cream (for the blood test) arm with distraction from nurse/parents +/-anesthesic and anxiolytic gas and the experimental arm is the local anesthetic cream + virtual reality mask distraction

The nurse informs and obtains the consent of the child and his parents. Then she measures child's pain and anxiety before the care, during the blood test, at the third prick test and immediately after the care.

研究设计

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

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from 7 to 13 years old requiring blood test and prick tests in pediatric consultation at the Clermont-Ferrand University Hospital and in the pediatric's day hospital at the Saint-Etienne University Hospital
  • Subjects and their parents who were informed about the study and gave informed consent
  • Enrollment in the Social Security system
  • Children and parents able to use the self-report scales proposed in the study

排除标准

  • Children from 7 to 13 :
  • presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post-traumatic stress disorder)
  • Having a modification of pain's integration (spina bifida for example)
  • Having received an analgesic before the care
  • Requiring contact isolation
  • With a history of seizures or motion sickness
  • Refusal of the parents and/or the child

研究组 & 干预措施

standard

Active Comparator

Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas

干预措施: control arm (Other)

virtual reality

Experimental

Use local anesthesic cream and virtual reality mask

干预措施: Virtual reality mask (Device)

结局指标

主要结局

children's pain hetero-evaluation

时间窗: during procedure (prick test)

children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score

children's pain self-evaluation

时间窗: 5 min after the care

self evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10=worst score

次要结局

  • children's anxiety hetero evaluation(during procedure (prick tests))
  • evaluation of the care(5 min after the care)
  • change from baseline children's anxiety at just after the care(before the care and 5 min after the care)
  • change from baseline parents' anxiety at just after the care(before the care and 5 min after the care)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (4)

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