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

Not Applicable

Recruiting

• Conditions: Episiotomy Wound; Anxiety; Perineum; Injury
• Interventions: Device: Virtual Reality for Anxiety Reduction

• Registration Number: NCT04693013
• Lead Sponsor: Ziv Hospital

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 Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study Start: 2021-01-01
• Study First Posted: 2021-01-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Virtual Reality for Anxiety Reduction	use of virtual reality (VR)

Primary Outcome Measures

Name	Time	Method
Anxiety Level	Immediately after procedure	questionairre

Secondary Outcome Measures

Name	Time	Method
Pain Level	Immediately after procedure	questionairre

Trial Locations

Locations (1)

David Peleg; 🇮🇱 Safed, Israel