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NCT04693013 Clinical Trial

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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04693013
Other study ID # 0103-20-ZIV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date April 30, 2024

Study information
Verified date July 2023
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 84
Est. completion date April 30, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Post-partum vaginal delivery, spontaneous or instrumental - Episiotomy or 1st or 2nd degree perineal tear - informed consent Exclusion Criteria: - Cesarean delivery - 3rd or 4th degree perineal tear - no informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Virtual Reality for Anxiety Reduction
Virtual Reality for Anxiety Reduction during suturing of perineum

Locations
Country Name City State
Israel David Peleg Safed

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety Level questionairre Immediately after procedure
Secondary Pain Level questionairre Immediately after procedure
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