Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340672
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-17
Brief Title:
The Effect of AR in Patient Pre-operative Education
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Effect of Augmented Reality in Patient Pre-operative Education
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The purpose of this clinical trial is to analyze the effect of augmented reality AR on patient education and overall satisfaction when used during preoperative counseling in adults undergoing spinal surgery The main aims of this study are
Aim 1 To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction higher levels of confidence in surgeons lower levels of preoperative anxiety and lower patient reported pain scores
Aim 2 To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals
This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices
Aim 1 To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction higher levels of confidence in surgeons lower levels of preoperative anxiety and lower patient reported pain scores
Aim 2 To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals
This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices
Detailed Description:
This study will be performed on patients scheduled to undergo elective spinal surgery The study will be a non-blinded randomized clinical trial with a treatment arm and a control arm After patient screening to determine eligibility and after patients are informed about the study and potential risks all patients giving written informed consent will be randomized in a non-blinded manner in a 11 ratio to traditional preoperative patient counseling control arm or AR enhanced preoperative patient counseling treatment arm In the traditional preoperative patient counseling group surgeons will explain the patients pathology and the surgery with only words and with or without pictures MRI CT etc andor a generic 3D model In the AR enhanced preoperative patient counseling group the surgeon will have virtual interactive models of the patients own anatomy projected through AR to show patients while describing the problem and how the surgery will be performed
For all patients included within the treatment arm the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection When using Surgical AR patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System PACS on the Medivis workstation During preoperative consultation the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset For AnatomyX a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient patient family and surgeon can exist
For all patients included within the treatment arm the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection When using Surgical AR patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System PACS on the Medivis workstation During preoperative consultation the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset For AnatomyX a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient patient family and surgeon can exist
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