Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280222
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-07
Brief Title:
The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Virtual Reality VR-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
VRFORANXIETY
Brief Summary:
A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level
Detailed Description:
Eligible women undergoing elective egg freezing will be offered to participate in the study and sign a consent form
The patients will be randomized into 2 groups
1 No intervention routine management
2 Exposure to scenery video as a VR virtual reality session
All women will be addressed prior to the procedure while they are waiting and upon consent will be asked to state their VAS visual analogue scale anxiety score and to fill the STAI The State-Trait Anxiety Inventory questionnaire Vital signs Heart rate Blood pressure will be recorded upon arrival
Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again vital signs will be recorded again
After recovery all women will fill the STAI questionnaire VAS score and vital signs before they will be discharged
The patients will be randomized into 2 groups
1 No intervention routine management
2 Exposure to scenery video as a VR virtual reality session
All women will be addressed prior to the procedure while they are waiting and upon consent will be asked to state their VAS visual analogue scale anxiety score and to fill the STAI The State-Trait Anxiety Inventory questionnaire Vital signs Heart rate Blood pressure will be recorded upon arrival
Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again vital signs will be recorded again
After recovery all women will fill the STAI questionnaire VAS score and vital signs before they will be discharged
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