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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Episiotomy Wound; Perineum; Injury
• Intervention / Treatment: Device: Virtual Reality for Anxiety Reduction

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, 13100
    • Recruiting
    • David Peleg
    • Contact: David Peleg, MD; Phone Number: 0506263782; Email: david.p@ziv.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; use of virtual reality (VR)	Device: Virtual Reality for Anxiety Reduction; Virtual Reality for Anxiety Reduction during suturing of perineum
No Intervention: Control; no use of VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Level	questionairre	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	questionairre	Immediately after procedure

Collaborators and Investigators

• Sponsor: Ziv Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Anxiety Disorders; Lacerations
• Other Study ID Numbers: 0103-20-ZIV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No