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Clinical Trial Summary

Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04693013
Study type Interventional
Source Ziv Hospital
Contact
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date April 30, 2024

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