跳至主要内容
临床试验/NCT03888690
NCT03888690Unknown不适用

Randomized Controlled Trial Evaluating the Effectiveness of the Virtual Reality Distraction Compared to Current Practice, on Reducing Procedural Pain in Children and Adolescents Supported in Pediatric Onco-Hematology Unit.

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
96
试验地点
2
主要终点
Pain scores

研究概览

简要总结

  • Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice.
  • Evaluate the impact of VR on the level of anxiety induced by invasive procedures
  • Report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques.
  • Evaluate the impact of VR on the short-term consequences of procedural pain, especially in terms of phobia of care.

详细描述

Diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. These are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of Hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...).

The short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention.

The quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. The non-pharmacological methods are numerous and still insufficiently used by the care teams. Virtual Reality is on interesting option.

研究设计

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

入排标准

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

入选标准

  • Children or Adolescent supported in onco-hematologic unit.

排除标准

  • Serious behavioral disorders
  • Serious neurosensory deficit

研究组 & 干预措施

With and then without VR

Active Comparator

Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR.

干预措施: Virtual Reality Headset (Device)

Without and then with VR

Active Comparator

Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention.

干预措施: Virtual Reality Headset (Device)

结局指标

主要结局

Pain scores

时间窗: 1 hour

Analogical visual scale

次要结局

  • Anxiety scores(1 hour)
  • Traceability of the procedure(12 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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