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Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
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.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
David Peleg
Safed, Israel
Start Date
January 1, 2021
Primary Completion Date
March 1, 2024
Completion Date
April 30, 2024
Last Updated
July 25, 2023
84
ESTIMATED participants
Virtual Reality for Anxiety Reduction
DEVICE
Lead Sponsor
Ziv Hospital
NCT07478393
NCT07456631
Data Source & Attribution
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