NCT06340672

The Effect of AR in Patient Pre-operative Education

The Effect of Augmented Reality in Patient Pre-operative Education

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 1:1 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) and/or 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.

Conditions

• Anterior Cervical Discectomy and Fusion

Interventions

Type	Name	Description
OTHER	Augmented Reality Enhanced Preoperative Counseling	For patients undergoing AR enhanced preoperative counseling, headset-based AR holograms of standardized patient anatomy through AnatomyX as well as patient specific anatomy through SurgicalAR will be projected to assist the surgeon in educating the patient throughout preoperative counseling.
OTHER	Standard preoperative counseling	Control patients will undergo standard preoperative counseling.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-13
• Completion: 2025-05-13
• First posted: 2024-04-01
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States