NCT04693013

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

December 31, 2020

Last Update Submit

July 24, 2023

Conditions

Perineum; InjuryEpisiotomy WoundAnxiety

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level

    questionairre

    Immediately after procedure

Secondary Outcomes (1)

  • Pain Level

    Immediately after procedure

Study Arms (2)

Interventional

EXPERIMENTAL

use of virtual reality (VR)

Device: Virtual Reality for Anxiety Reduction

Control

NO INTERVENTION

no use of VR

Interventions

Virtual Reality for Anxiety ReductionDEVICE

Virtual Reality for Anxiety Reduction during suturing of perineum

Interventional

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post-partum vaginal delivery, spontaneous or instrumental
  • Episiotomy or 1st or 2nd degree perineal tear
  • informed consent

You may not qualify if:

  • Cesarean delivery
  • rd or 4th degree perineal tear
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Peleg

Safed, 13100, Israel

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff physician

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2024

Study Completion

April 30, 2024

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

IL(1)