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Clinical Trials/NCT04693013
NCT04693013
Recruiting
Not Applicable

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

Ziv Hospital1 site in 1 country84 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perineum; Injury
Sponsor
Ziv Hospital
Enrollment
84
Locations
1
Primary Endpoint
Anxiety Level
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ziv Hospital
Responsible Party
Principal Investigator
Principal Investigator

David Peleg

staff physician

Ziv Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Anxiety Level

Time Frame: Immediately after procedure

questionairre

Secondary Outcomes

  • Pain Level(Immediately after procedure)

Study Sites (1)

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