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临床试验/NCT04737668
NCT04737668已完成不适用

Virtual Reality During Intrathecal Pump Refills in Children: a Randomised Controlled Trial With Crossover Design

Moens Maarten2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Moens Maarten
入组人数
6
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

The aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.

详细描述

Virtual reality (VR) is a technological rehabilitation tool that allows the user to experience the interaction with a computer-generated environment. It may provide some advantages over conventional care: it allows the simulation of realistic environments and patients feel more motivated by this kind of virtual environment. VR constitutes an enriched environment with augmented multiple sensory feedbacks (auditory, visual, tactile VR enriched environment) that has already shown some efficiency in reducing chronic pain. There is mounting evidence from acute pain conditions, such as wound care, that VR could play a role as an additional treatment method to relieve pain A possible explanation for its mechanism of action is provided by "the gate-theory of attention". VR reduces the perception of pain by diverting attention away from the pain. Most children experience pain and fear when receiving a medical treatment; two feelings which are closely related and affecting one another. Moreover, children often describe procedures involving needles as the most stressful portion of the hospital experience. Children who have been implanted with an intrathecal baclofen (ITB) pump, need to come to the hospital for a refill approximately every 3 months, depending on the exact dose. During the refill, the physician places a needle directly into the reservoir to refill the pump. To alleviate the pain and fear with these refill procedures, it is hypothesized that VR could alleviate pain and make these refills more feasible. Therefore, the aim of this study is to evaluate whether VR is reducing pain during a refill procedure, in children receiving intrathecal drug delivery compared to usual care.

研究设计

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

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with cerebral palsy between 8 and 16 years who have an implanted pump for intrathecal drug delivery
  • Child and parents have been informed of the study procedures and have given written informed consent
  • Child and parents willing to comply with study protocol
  • Child and parents are able to speak Dutch/French (questionnaires)
  • Cognitive and language functioning enabling communication between the physician/researcher and the child

排除标准

  • Children with susceptibility to motion sickness or cyber-sickness
  • Children with susceptibility to claustrophobia
  • History of seizures/epilepsia

结局指标

主要结局

Pain intensity

时间窗: Through study completion, an average of 6 months.

Pain intensity will be assessed with the Wong-Baker FACES scale in children, parents, physician and researcher, to evaluate differences in the 3 conditions (usual refill, refill with VR and refill with distraction).

次要结局

  • Anxiety(Through study completion, an average of 6 months.)
  • Fear(Through study completion, an average of 6 months.)
  • Statisfaction(Through study completion, an average of 6 months.)
  • Procedural pain(Through study completion, an average of 6 months.)
  • Adverse events(Through study completion, an average of 6 months.)

研究者

发起方
Moens Maarten
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Moens Maarten

principal investigator

Universitair Ziekenhuis Brussel

研究点 (2)

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