Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide

October 26, 2020 updated by: Assaf-Harofeh Medical Center

The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel, 70300
        • Recruiting
        • Asaf ha Rofeh, MC
        • Contact:
          • Ran Svirsky, Doctor of Medicine
          • Phone Number: +9729779000
          • Email: rsvirs@gmail.com
        • Principal Investigator:
          • Ran Svirsky, Doctor of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Pregnant women undergoing amniocentesis/foeticide who will sign an informed consent form

-

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: women using virtual glass during amniocentesis/foeticide
Device: virtual reality glasses
In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.
No Intervention: women undergoing amniocentesis/foeticide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: Up to one hour before the procedure
Spielberger's State-Trait Anxiety Inventory
Up to one hour before the procedure
Anxiety level
Time Frame: Up to one hour after the procedure
Spielberger's State-Trait Anxiety Inventory
Up to one hour after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

July 26, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0182-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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