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