Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 5:43 AM
Study NCT ID:
NCT04802460
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study
Status:
COMPLETED
Status Verified Date:
2021-03
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:
The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.
Detailed Description:
The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).
A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.
A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.
Study Oversight
Has Oversight DMC:
False
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?: