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

Anxiety Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491149
• Other study ID #: #0182-19
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 2021

Study information

• Verified date: May 2020
• Source: Assaf-Harofeh Medical Center
• Contact: Ran Svirsky, MD
• Phone: 972-89779000
• Email: rsvirs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Amniocentesis
• Anxiety Acute
• Anxiety Disorders
• Foeticide

Intervention

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

Locations

Country	Name	City	State
Israel	Asaf ha Rofeh, MC	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Spielberger's State-Trait Anxiety Inventory	Up to one hour before the procedure
Primary	Anxiety level	Spielberger's State-Trait Anxiety Inventory	Up to one hour after the procedure