Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534086
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Virtual Reality for Urological Procedures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious However given the conscious nature of these procedures patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia Stressors such as hearing surgical terminology technical discussion and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries
The current study will examine the feasibility and pilot outcomes of Virtual Reality VR guided meditation therapy during cystoscopies and vasectomies Feasibility will be examined through 1 recruitment capability and resulting sample characteristics 2 data collection procedures including randomization and outcome measures and 3 participant acceptability and suitability of the VR intervention during the procedures The investigators will also evaluate pilot outcomes of the VR intervention on pain anxiety and overall satisfaction with the procedure Results of this study will inform the development of a large-scale randomized clinical trial RCT to evaluate the efficacy of this intervention
Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure
The current study will examine the feasibility and pilot outcomes of Virtual Reality VR guided meditation therapy during cystoscopies and vasectomies Feasibility will be examined through 1 recruitment capability and resulting sample characteristics 2 data collection procedures including randomization and outcome measures and 3 participant acceptability and suitability of the VR intervention during the procedures The investigators will also evaluate pilot outcomes of the VR intervention on pain anxiety and overall satisfaction with the procedure Results of this study will inform the development of a large-scale randomized clinical trial RCT to evaluate the efficacy of this intervention
Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None