Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of Pain
研究概览
简要总结
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.
详细描述
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.
Although a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.
The studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.
Nonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures
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 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB
排除标准
- •Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.
- •Psychological ,hearing or visual disorders.
- •known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .
- •Previous history of failed office hysteroscopy
- •Patients scheduled for operative hysteroscopy.
结局指标
主要结局
Assessment of Pain
时间窗: 10 minutes from starting the procedure
The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)
次要结局
未报告次要终点
