Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
NCT ID: NCT04693013
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2021-01-01
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Interventional
use of virtual reality (VR)
Virtual Reality for Anxiety Reduction
Virtual Reality for Anxiety Reduction during suturing of perineum
Control
no use of VR
No interventions assigned to this group
Interventions
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Virtual Reality for Anxiety Reduction
Virtual Reality for Anxiety Reduction during suturing of perineum
Eligibility Criteria
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Inclusion Criteria
* Episiotomy or 1st or 2nd degree perineal tear
* informed consent
Exclusion Criteria
* 3rd or 4th degree perineal tear
* no informed consent
18 Years
45 Years
FEMALE
No
Sponsors
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Ziv Hospital
OTHER_GOV
Responsible Party
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David Peleg
staff physician
Locations
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David Peleg
Safed, , Israel
Countries
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Facility Contacts
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Other Identifiers
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0103-20-ZIV
Identifier Type: -
Identifier Source: org_study_id
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