The Effect of AR in Patient Pre-operative Education

University of Pittsburgh

Status: Terminated

Conditions: Anterior Cervical Discectomy and Fusion

Treatments: Other: Standard preoperative counseling; Other: Augmented Reality Enhanced Preoperative Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT06340672

STUDY24010034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years-of-age
• Undergoing elective anterior cervical discectomy and fusion (ACDF)

Exclusion criteria

• Prior surgery
• Vestibular dysfunction
• Cannot tolerate AR immersion secondary to physical or psychiatric impairments
• Cognitive impairment
• Emergency procedures

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Standard Patient Pre-operative Counseling

Active Comparator group

Description:

These patients will undergo standard preoperative counseling. A standardized checklist will designate the mandatory information patients must receive during counseling including a description of the normal elements of the anatomy and abnormal elements of the anatomy relevant to each patient, a description of the basic steps of the surgical procedure and how it addresses each patient's individual problem, and a description of the potential risks, complications, and benefits of the procedure. Surgeons may augment the verbal descriptions of the preoperative counseling procedure with patient 2D MRI or CT imaging or generic 3D models or drawings. However, customized patient specific 3D printed models are not allowed.

Treatment:

Other: Standard preoperative counseling

Augmented Reality Enhanced Patient Pre-operative Counseling

Experimental group

Description:

This group of patients will undergo AR enhanced preoperative counseling. Surgeons will be provided with the same checklist of mandatory minimum information patients must receive during counseling as the control group. Both the patient and physician will wear an AR-headset. Medivis AnatomyX, a generic holographic anatomy visualization available on all AR-headset devices, will first be used to introduce the patient to normal anatomy and describe the steps of the procedure. Using Surgical AR, the patients specific imaging will then be accessed through the Medivis mobile workstation and projected into a 3D interactive model. The surgeon will use this model to highlight the patients pathology, explain how it is causing their symptoms, and review possible complications. The surgeon may refer back to the generic model in AnatomyX at any point during counseling.

Treatment:

Other: Augmented Reality Enhanced Preoperative Counseling