Viewing Study NCT05941390



Ignite Creation Date: 2024-05-06 @ 7:14 PM
Last Modification Date: 2024-10-26 @ 3:03 PM
Study NCT ID: NCT05941390
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-08-03
First Post: 2023-06-05

Brief Title: Using Virtual Reality VR Technology in Gynecological and Obstetrics Procedures
Sponsor: Assuta Ashdod Hospital
Organization: Assuta Ashdod Hospital

Study Overview

Official Title: Using Virtual Reality VR Technology in Gynecological Procedures
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VR
Brief Summary: A randomized control trial will be conducted in Assuta Ashdod hospital in the department of obstetrics and gynecology Pregnant and non pregnant women undergoing one of the procedures external cephalic versionamniocentesis or hysteroscopy will be approached All willing patients meeting the criteria will sign an informed consent form will

After signing informed consent patients will be randomly allocated into three groups1 control no use of VR 2 use of VR googles without positive psychology 3 use of VR googles with positive psychology

Before and after the procedure each group will answer pain and anxiety questionnaires In addition following following each procedure salivary cortisol levels will be measured
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None