NCT04491149

Brief Summary

Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain. The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 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

June 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

June 14, 2020

Last Update Submit

October 26, 2020

Conditions

Anxiety AcuteAmniocentesisFoeticide

Outcome Measures

Primary Outcomes (2)

  • Anxiety level

    Spielberger's State-Trait Anxiety Inventory

    Up to one hour before the procedure

  • Anxiety level

    Spielberger's State-Trait Anxiety Inventory

    Up to one hour after the procedure

Study Arms (2)

women using virtual glass during amniocentesis/foeticide

EXPERIMENTAL
Device: virtual reality glasses

women undergoing amniocentesis/foeticide

NO INTERVENTION

Interventions

virtual reality glassesDEVICE

In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.

women using virtual glass during amniocentesis/foeticide

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Women younger than 18 years
  • Twin pregnancies
  • Women with vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf ha Rofeh, MC

Zrifin, 70300, Israel

RECRUITING

Central Study Contacts

Ran Svirsky, MD

CONTACT

972-89779000rsvirs@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2020

First Posted

July 29, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

October 27, 2020

Record last verified: 2020-05

Locations

IL(1)