Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Anxiety Level
研究概览
简要总结
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
详细描述
Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman.
The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level.
84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS.
Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-partum vaginal delivery, spontaneous or instrumental
- •Episiotomy or 1st or 2nd degree perineal tear
- •informed consent
排除标准
- •Cesarean delivery
- •3rd or 4th degree perineal tear
- •no informed consent
结局指标
主要结局
Anxiety Level
时间窗: Immediately after procedure
questionairre
次要结局
- Pain Level(Immediately after procedure)
研究者
David Peleg
staff physician
Ziv Medical Center
