Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Change in pain severity
研究概览
简要总结
In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter
详细描述
Insertion of Extra-Amniotic Balloon (EAB) is a recommend mechanical method of Induction of labour. This method of induction causes the cervix to dilate through mechanical pressure on the cervix.
During the procedure of insertion the women is lying on her back. Insertion of EAB is performed by conventional means.
The insertion of EAB can involve discomfort, pain and anxiety before and during the procedure.
While there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period.
The "Virtual Reality" (VR) technology is a simple non-invasive technology. The advantage of VR is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. This technology uses processes of sight, and hearing that requires attention.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women going through mechanical induction of labour with Extra-Amniotic Balloon
排除标准
- •Women with history of migraine, headache, epilepsy, vestibular disorders
- •Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures
结局指标
主要结局
Change in pain severity
时间窗: 1 hour
Subjective assessment of the degree of pain would be graded according to the VAS (Visual Analogue Scale) which is a scale used to measure subjective pain intensity according to a pain scale of 0 to 10, An objective pain assessment will be performed by measuring a pulse at a predetermined time points.
次要结局
- Change in Anxiety state(1 hour)
研究者
ilia kleiner
Obstetrics and Gynecology Resident, MD, Principal investigator
Wolfson Medical Center