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Clinical Trials/NCT04693013
NCT04693013RecruitingNot Applicable

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

Ziv Hospital1 site in 1 country84 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Anxiety Level

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Interventional

Experimental

use of virtual reality (VR)

Intervention: Virtual Reality for Anxiety Reduction (Device)

Control

No Intervention

no use of VR

Outcomes

Primary Outcomes

Anxiety Level

Time Frame: Immediately after procedure

questionairre

Secondary Outcomes

  • Pain Level(Immediately after procedure)

Investigators

Sponsor
Ziv Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

David Peleg

staff physician

Ziv Medical Center

Study Sites (1)

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