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

Sponsor
Ziv Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04693013
Collaborator
(none)
84
Enrollment
2
Arms
10.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality for Anxiety Reduction
 N/A

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
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety Level [Immediately after procedure]

    questionairre

Secondary Outcome Measures

  1. Pain Level [Immediately after procedure]

    questionairre

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ziv Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Peleg, staff physician, Ziv Medical Center
ClinicalTrials.gov Identifier:
NCT04693013
Other Study ID Numbers:
  • 0103-20-ZIV
First Posted:
Jan 5, 2021
Last Update Posted:
Jan 5, 2021
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lacerations
Anxiety Disorders

Study Results

No Results Posted as of Jan 5, 2021