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临床试验/NCT05830513
NCT05830513尚未招募不适用

OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial

Luzerner Kantonsspital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
VAS

研究概览

简要总结

In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.

研究设计

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

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 and 43 years
  • IVF with follicular aspiration of one to tree follicles
  • Written informed consent signed by the participant must be obtained prior to OPU

排除标准

  • OPU with more than tree follicular aspiration
  • Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV)
  • Application of analgesics within eight hours before OPU
  • hearing impairments
  • migraines
  • seizure disorder
  • vestibular abnormalities
  • history of motion sickness

结局指标

主要结局

VAS

时间窗: post OPU (line from 0: no pain to 10:worst pain) immediately post OPU

visual analogue scale pain scoring

次要结局

  • VAS for anxiety(Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU)
  • vital parameters: blood pressure(Intraoperative)
  • state-trait anxiety inventory form (STAI)(Pre-OPU)
  • vital parameters: pulse rate(Intraoperative)
  • vital parameters : oxygen saturation(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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