The Effect of AR in Patient Pre-operative Education

Not Applicable

Terminated

• Conditions: Anterior Cervical Discectomy and Fusion
• Interventions: Other: Standard preoperative counseling; Other: Augmented Reality Enhanced Preoperative Counseling

• Registration Number: NCT06340672
• Lead Sponsor: University of Pittsburgh

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.

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.

Study Timeline

• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-01
• Study Start: 2024-09-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-13
• Study Completion: 2025-05-13
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Patient Pre-operative Counseling	Standard preoperative counseling	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.
Augmented Reality Enhanced Patient Pre-operative Counseling	Augmented Reality Enhanced Preoperative Counseling	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.

Primary Outcome Measures

Name	Time	Method
Degree of knowledge acquisition questionnaire 2 weeks post-operative	Knowledge acquisition will be completed approximately 2 weeks post-operatively	Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling	The APAIS is to be completed within 24 hours after preoperative counseling	The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety.
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey	The APAIS is to be completed preoperatively on the day of the surgery	The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety.
Degree of knowledge acquisition questionnaire 6 months post-operative	Knowledge acquisition will be completed approximately 6 months post-operatively	Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Participant age	This will be documented within 24 hours after enrollment	The patients age at the time of the intervention will be recorded
Simulator Sickness Questionnaire (SSQ)	The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient preoperative counseling	The SSQ is used to quantify simulator sickness within individuals during or following the use of extended reality environments across 3 domains. The total score ranges from 0-235.62 with higher scores representing higher sickness.
Evaluation of the Experience of General Anesthesia (EVAN-G) Survey	The EVAN-G will be completed within 24 hours after surgery	The EVAN-G is a patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
Participant's indication for surgery	This will be completed within 24 hours after enrollment	The patients primary diagnosis that is the reason for surgery will be recorded
Participant's past surgeries	This will be completed within 24 hours after enrollment	A list of the surgeries the patient has had in the past will be recorded
Doses of pain medications	This will be completed within 24 hours after enrollment	The dose of each pain medication a patient is taking at the time of the intervention will be recorded
Prior experience with simulated environments	This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm	This will be assessed using a Likert 1-5 scale with 1 being no experience with extended reality environments and 5 being very experienced with extended reality environments
Patient understanding of surgery 2 weeks post-operative	Patient understanding will be assessed approximately 2 weeks post-operatively	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient understanding of surgery 6 months post-operative	Patient understanding will be assessed approximately 6 months post-operatively	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Time of preoperative patient counseling	Assessed during preoperative patient counseling session	The total time it takes for a surgeon to perform preoperative patient counseling will be recorded.
Degree of knowledge acquisition questionnaire preoperatively	Knowledge acquisition will be completed preoperatively on the the day of surgery	Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Degree of knowledge acquisition questionnaire 3 months post-operative	Knowledge acquisition will be completed approximately 3 months post-operatively	Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Participant gender	This will be completed within 24 hours after enrollment	The patients gender will be recorded
Patient understanding of surgery at baseline	Patient understanding will be assessed within 24 hours after preoperative counseling	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient understanding of surgery 3 months post-operative	Patient understanding will be assessed approximately 3 months post-operatively	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient pain level 3 months post-operatively	Pain level will be assessed approximately 3 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Patient satisfaction level with the surgical explanation at baseline	Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 2 weeks post-operatively	Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 3 months post-operatively	Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient surgery satisfaction level 2 weeks post-operatively	Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient surgery satisfaction level 6 months post-operatively	Patient surgery satisfaction will be assessed approximately 6 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Degree of knowledge acquisition questionnaire at baseline	Knowledge acquisition will be completed within 24 hours after preoperative counseling	Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction.
Confidence in surgeon preoperatively	Confidence in surgeon will be assessed preoperatively on the the day of surgery	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Confidence in surgeon 2 weeks post-operatively	Confidence in surgeon will be assessed approximately 2 weeks post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient surgery visit satisfaction level 3 months post-operatively	Patient surgery satisfaction will be assessed approximately 3 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient pain level expectation preoperatively	Pain level expectation will be assessed preoperatively on the the day of surgery	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon at baseline	Confidence in surgeon will be assessed within 24 hours after preoperative counseling	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Participant education	This will be completed within 24 hours after enrollment	The patients number of years of formal education will be recorded
Names of pain medications	This will be completed within 24 hours after enrollment	The name of each pain medication a patient is taking at the time of the intervention will be recorded
Patient pain level 2 weeks post-operatively	Pain level will be assessed approximately 2 weeks post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon 6 months post-operatively	Confidence in surgeon will be assessed approximately 6 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient visit satisfaction level preoperatively	Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient satisfaction level with the surgical explanation preoperatively	Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient postoperative visit satisfaction level 6 months post-operatively	Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively	A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Patient understanding of surgery preoperatively	Patient understanding will be assessed preoperatively on the the day of surgery	A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Patient pain level expectation at baseline	Pain level expectation will be assessed within 24 hours after preoperative counseling	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Patient pain level 6 months post-operatively	Pain level will be assessed around 6 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Confidence in surgeon 3 months post-operatively	Confidence in surgeon will be assessed approximately 3 months post-operatively	A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Patient visit satisfaction level at baseline	Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling	A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied

Secondary Outcome Measures

Name	Time	Method
Patient retention rates	Patient retention rates will be assessed up to 6 months post-operatively	Patient retention rates will be tracked for 6 months following surgical intervention
Patient preference on the type of preoperative counseling received for the AR-specific participants	This will be assessed immediately following preoperatiive counseling within the treatment group	Within the AR enhanced preoperative counseling treatment group, an additional preoperative variable collected will be if the patient found generic anatomy through AnatomyX, their own anatomy through SurgicalAR, or both the best method for AR counseling
Patient referral rates	Patient referral rates will be assessed up to 6 months post-operatively	Patient referral rates will be tracked for 6 months following surgical intervention

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States