Back to resultsStudy on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide
Primary Purpose
Anxiety Acute, Amniocentesis, Foeticide
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
virtual reality glasses
Sponsored by
About this trial
This is an interventional other trial for Anxiety Acute
Eligibility Criteria
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
Sites / Locations
- Asaf ha Rofeh, MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
women using virtual glass during amniocentesis/foeticide
women undergoing amniocentesis/foeticide
Arm Description
Outcomes
Primary Outcome Measures
Anxiety level
Spielberger's State-Trait Anxiety Inventory
Anxiety level
Spielberger's State-Trait Anxiety Inventory
Secondary Outcome Measures
Full Information
NCT ID
NCT04491149
First Posted
June 14, 2020
Last Updated
October 26, 2020
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04491149
Brief Title
Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide
Official Title
The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Acute, Amniocentesis, Foeticide
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
women using virtual glass during amniocentesis/foeticide
Arm Type
Experimental
Arm Title
women undergoing amniocentesis/foeticide
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
virtual reality glasses
Intervention Description
In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.
Primary Outcome Measure Information:
Title
Anxiety level
Description
Spielberger's State-Trait Anxiety Inventory
Time Frame
Up to one hour before the procedure
Title
Anxiety level
Description
Spielberger's State-Trait Anxiety Inventory
Time Frame
Up to one hour after the procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Svirsky, MD
Phone
972-89779000
Email
rsvirs@gmail.com
Facility Information:
Facility Name
Asaf ha Rofeh, MC
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Svirsky, Doctor of Medicine
Phone
+9729779000
Email
rsvirs@gmail.com
First Name & Middle Initial & Last Name & Degree
Ran Svirsky, Doctor of Medicine
12. IPD Sharing Statement
Learn more about this trial
Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide
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