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临床试验/NCT04693013
NCT04693013招募中不适用

Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration

Ziv Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年1月1日最近更新:
适应症

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

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

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

David Peleg

staff physician

Ziv Medical Center

研究点 (2)

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