Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Primary Purpose
Perineum; Injury, Episiotomy Wound, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Virtual Reality for Anxiety Reduction
Sponsored by
About this trial
This is an interventional prevention trial for Perineum; Injury
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
Sites / Locations
- David PelegRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional
Control
Arm Description
use of virtual reality (VR)
no use of VR
Outcomes
Primary Outcome Measures
Anxiety Level
questionairre
Secondary Outcome Measures
Pain Level
questionairre
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04693013
Brief Title
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Official Title
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziv Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineum; Injury, Episiotomy Wound, Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
use of virtual reality (VR)
Arm Title
Control
Arm Type
No Intervention
Arm Description
no use of VR
Intervention Type
Device
Intervention Name(s)
Virtual Reality for Anxiety Reduction
Intervention Description
Virtual Reality for Anxiety Reduction during suturing of perineum
Primary Outcome Measure Information:
Title
Anxiety Level
Description
questionairre
Time Frame
Immediately after procedure
Secondary Outcome Measure Information:
Title
Pain Level
Description
questionairre
Time Frame
Immediately after procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
David Peleg
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peleg, MD
Phone
0506263782
Email
david.p@ziv.gov.il
12. IPD Sharing Statement
Learn more about this trial
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
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