Augmented Reality for Neck Surgery Preparation

N/A

Recruiting

Led By Edward Andrews, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pain level will be assessed around 6 months post-operatively

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using augmented reality during preoperative counseling for older adults undergoing spinal surgery can improve patient satisfaction, confidence in surgeons, reduce anxiety, and pain levels. It also wants to see

Who is the study for?

This trial is for older adults who are about to undergo spinal surgery, specifically neck surgery or Transforaminal Lumbar Interbody Fusion. Participants should be interested in how pre-operative education is delivered and willing to experience a new technology (AR) as part of their surgical preparation.

What is being tested?

The study is testing if using Augmented Reality (AR) during pre-op consultations can improve patient satisfaction, confidence in surgeons, reduce anxiety and pain levels compared to standard counseling. It will also see if AR improves understanding of the surgery and increases retention rates and referrals.

What are the potential side effects?

Since this trial involves non-invasive educational tools rather than medication or medical procedures, there are no direct physical side effects expected from participating in either form of preoperative counseling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pain level will be assessed around 6 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pain level will be assessed around 6 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and pain level will be assessed around 6 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amsterdam Preoperative Anxiety and Information Score (APAIS) survey

Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling

Confidence in surgeon 2 weeks post-operatively

+40 more

Secondary study objectives

Patient preference on the type of preoperative counseling received for the AR-specific participants

Patient referral rates

Patient retention rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Augmented Reality Enhanced Patient Pre-operative CounselingExperimental Treatment1 Intervention

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.

Group II: Standard Patient Pre-operative CounselingActive Control1 Intervention

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.

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