Anterior Cervical Discectomy and FusionNCT06340672
The Effect of AR in Patient Pre-operative Education
A study testing Augmented Reality Enhanced Preoperative Counseling and Standard preoperative counseling in people with Anterior Cervical Discectomy and Fusion, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Cervical Discectomy and Fusion
- What is being tested?
- Augmented Reality Enhanced Preoperative Counseling and Standard preoperative counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 13 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years-of-age
- Undergoing elective anterior cervical discectomy and fusion (ACDF)
Who cannot join
- Prior surgery
- Vestibular dysfunction
- Cannot tolerate AR immersion secondary to physical or psychiatric impairments
- Cognitive impairment
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Augmented Reality in Patient Pre-operative Education
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.
Read more
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.
Read the 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
- Being tested
- Augmented Reality Enhanced Preoperative Counseling, Standard preoperative counseling
- Keywords
- Augmented Reality, Preoperative Counseling, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Enhanced Preoperative CounselingOther
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.
Standard preoperative counselingOther
Control patients will undergo standard preoperative counseling.
| Study group | Role | What they receive |
|---|---|---|
| Standard Patient Pre-operative Counseling | Active comparator | 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. Receives: Other: Standard preoperative counseling |
| Augmented Reality Enhanced Patient Pre-operative Counseling | Experimental | 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. Receives: Other: Augmented Reality Enhanced Preoperative Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey 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.
Measured: The APAIS is to be completed within 24 hours after preoperative counseling
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey
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.
Measured: The APAIS is to be completed preoperatively on the day of the surgery
Simulator Sickness Questionnaire (SSQ)
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.
Measured: The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient preoperative counseling
Evaluation of the Experience of General Anesthesia (EVAN-G) Survey
The EVAN-G is a patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
Measured: The EVAN-G will be completed within 24 hours after surgery
Time of preoperative patient counseling
The total time it takes for a surgeon to perform preoperative patient counseling will be recorded.
Measured: Assessed during preoperative patient counseling session
Degree of knowledge acquisition questionnaire at baseline
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.
Measured: Knowledge acquisition will be completed within 24 hours after preoperative counseling
Degree of knowledge acquisition questionnaire preoperatively
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.
Measured: Knowledge acquisition will be completed preoperatively on the the day of surgery
Degree of knowledge acquisition questionnaire 2 weeks post-operative
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.
Measured: Knowledge acquisition will be completed approximately 2 weeks post-operatively
Degree of knowledge acquisition questionnaire 3 months post-operative
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.
Measured: Knowledge acquisition will be completed approximately 3 months post-operatively
Degree of knowledge acquisition questionnaire 6 months post-operative
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.
Measured: Knowledge acquisition will be completed approximately 6 months post-operatively
Participant age
The patients age at the time of the intervention will be recorded
Measured: This will be documented within 24 hours after enrollment
Participant gender
The patients gender will be recorded
Measured: This will be completed within 24 hours after enrollment
Participant's indication for surgery
The patients primary diagnosis that is the reason for surgery will be recorded
Measured: This will be completed within 24 hours after enrollment
Participant education
The patients number of years of formal education will be recorded
Measured: This will be completed within 24 hours after enrollment
Participant's past surgeries
A list of the surgeries the patient has had in the past will be recorded
Measured: This will be completed within 24 hours after enrollment
Names of pain medications
The name of each pain medication a patient is taking at the time of the intervention will be recorded
Measured: This will be completed within 24 hours after enrollment
Doses of pain medications
The dose of each pain medication a patient is taking at the time of the intervention will be recorded
Measured: This will be completed within 24 hours after enrollment
Prior experience with simulated environments
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
Measured: This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm
Patient understanding of surgery at baseline
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Measured: Patient understanding will be assessed within 24 hours after preoperative counseling
Patient understanding of surgery preoperatively
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Measured: Patient understanding will be assessed preoperatively on the the day of surgery
Patient understanding of surgery 2 weeks post-operative
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Measured: Patient understanding will be assessed approximately 2 weeks post-operatively
Patient understanding of surgery 3 months post-operative
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Measured: Patient understanding will be assessed approximately 3 months post-operatively
Patient understanding of surgery 6 months post-operative
A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear
Measured: Patient understanding will be assessed approximately 6 months post-operatively
Patient pain level expectation at baseline
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Measured: Pain level expectation will be assessed within 24 hours after preoperative counseling
Patient pain level expectation preoperatively
A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life.
Measured: Pain level expectation will be assessed preoperatively on the the day of surgery
Patient pain level 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.
Measured: Pain level will be assessed approximately 2 weeks post-operatively
Patient pain level 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.
Measured: Pain level will be assessed approximately 3 months post-operatively
Patient pain level 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.
Measured: Pain level will be assessed around 6 months post-operatively
Confidence in surgeon at baseline
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Measured: Confidence in surgeon will be assessed within 24 hours after preoperative counseling
Confidence in surgeon preoperatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Measured: Confidence in surgeon will be assessed preoperatively on the the day of surgery
Confidence in surgeon 2 weeks post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Measured: Confidence in surgeon will be assessed approximately 2 weeks post-operatively
Confidence in surgeon 3 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Measured: Confidence in surgeon will be assessed approximately 3 months post-operatively
Confidence in surgeon 6 months post-operatively
A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence
Measured: Confidence in surgeon will be assessed approximately 6 months post-operatively
Patient visit satisfaction level at baseline
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
Patient visit satisfaction level preoperatively
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery
Patient satisfaction level with the surgical explanation at baseline
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
Patient satisfaction level with the surgical explanation preoperatively
A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery
Patient postoperative visit satisfaction level 2 weeks post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively
Patient postoperative visit satisfaction level 3 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively
Patient postoperative visit satisfaction level 6 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively
Patient surgery satisfaction level 2 weeks post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively
Patient surgery visit satisfaction level 3 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient surgery satisfaction will be assessed approximately 3 months post-operatively
Patient surgery satisfaction level 6 months post-operatively
A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied
Measured: Patient surgery satisfaction will be assessed approximately 6 months post-operatively
Secondary outcomes (3)
Patient referral rates
Patient referral rates will be tracked for 6 months following surgical intervention
Measured: Patient referral rates will be assessed up to 6 months post-operatively
Patient retention rates
Patient retention rates will be tracked for 6 months following surgical intervention
Measured: Patient retention rates will be assessed up to 6 months post-operatively
Patient preference on the type of preoperative counseling received for the AR-specific participants
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
Measured: This will be assessed immediately following preoperatiive counseling within the treatment group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2024
- Primary completion13 May 2025
- Study completion13 May 2025
Why it stopped: Poor recruitment and subsequently untenable study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anterior Cervical Discectomy and FusionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Andrews, University of Pittsburgh
- Investigators
- Edward Andrews, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340672
- Sponsor's protocol ID
- STUDY24010034
- Status last verified
- May 2025
- First submitted
- 17 Mar 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
PubMed 27906757Collins MK, Ding VY, Ball RL, Dolce DL, Henderson JM, Halpern CH. Novel application of virtual reality in patient engagement for deep brain stimulation: A pilot study. Brain Stimul. 2018 Jul-Aug;11(4):935-937. doi: 10.1016/j.brs.2018.03.012. Epub 2018 Mar 15. No abstract available.
PubMed 29631869Eastwood D, Manson N, Bigney E, Darling M, Richardson E, Paixao R, Underwood T, Ellis K, Abraham E. Improving postoperative patient reported benefits and satisfaction following spinal fusion with a single preoperative education session. Spine J. 2019 May;19(5):840-845. doi: 10.1016/j.spinee.2018.11.010. Epub 2018 Nov 22.
PubMed 30471460Panesar SS, Magnetta M, Mukherjee D, Abhinav K, Branstetter BF, Gardner PA, Iv M, Fernandez-Miranda JC. Patient-specific 3-dimensionally printed models for neurosurgical planning and education. Neurosurg Focus. 2019 Dec 1;47(6):E12. doi: 10.3171/2019.9.FOCUS19511.
PubMed 31786547Rampersaud YR, Canizares M, Perruccio AV, Abraham E, Bailey CS, Christie SD, Evaniew N, Finkelstein JA, Glennie RA, Johnson MG, Nataraj A, Paquet J, Phan P, Weber MH, Thomas K, Manson N, Hall H, Fisher CG. Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. Neurosurgery. 2022 Jul 1;91(1):173-181. doi: 10.1227/neu.0000000000001981. Epub 2022 Apr 22.
PubMed 35442936Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
PubMed 33203047Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
PubMed 31113688Delgado CA, McCullers MR, Bloom SW. Evaluating the Efficacy of Surgical Consent. Am Surg. 2023 Aug;89(8):3433-3437. doi: 10.1177/00031348231161702. Epub 2023 Mar 15.
PubMed 36921342
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Augmented Reality in Patient Pre-operative Education
- ClinicalTrials.gov ID
- NCT06340672
- Acronym / sponsor ID
- STUDY24010034
- Conditions
- Anterior Cervical Discectomy and Fusion
- Keywords
- Augmented Reality, Preoperative Counseling, Patient Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment and subsequently untenable study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Patient Pre-operative Counseling | Active comparator | Other: Standard preoperative counselingThese 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 | Experimental | Other: Augmented Reality Enhanced Preoperative CounselingThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years-of-age
- Undergoing elective anterior cervical discectomy and fusion (ACDF)
Key exclusion criteria (5 listed)
- Prior surgery
- Vestibular dysfunction
- Cannot tolerate AR immersion secondary to physical or psychiatric impairments
- Cognitive impairment
- Emergency procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality Enhanced Preoperative CounselingFor 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 | Augmented Reality Enhanced Patient Pre-operative Counseling |
| Standard preoperative counselingControl patients will undergo standard preoperative counseling. | Other | Standard Patient Pre-operative Counseling |
Primary outcome
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling
Time frame: 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
Time frame: 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.
Simulator Sickness Questionnaire (SSQ)
Time frame: 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
Time frame: 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.
Time of preoperative patient counseling
Time frame: 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 at baseline
Time frame: 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.
Degree of knowledge acquisition questionnaire preoperatively
Time frame: 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 2 weeks post-operative
Time frame: 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.
Degree of knowledge acquisition questionnaire 3 months post-operative
Time frame: 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.
Degree of knowledge acquisition questionnaire 6 months post-operative
Time frame: 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
Time frame: This will be documented within 24 hours after enrollment
The patients age at the time of the intervention will be recorded
Participant gender
Time frame: This will be completed within 24 hours after enrollment
The patients gender will be recorded
Participant's indication for surgery
Time frame: This will be completed within 24 hours after enrollment
The patients primary diagnosis that is the reason for surgery will be recorded
Participant education
Time frame: This will be completed within 24 hours after enrollment
The patients number of years of formal education will be recorded
Participant's past surgeries
Time frame: This will be completed within 24 hours after enrollment
A list of the surgeries the patient has had in the past will be recorded
Names of pain medications
Time frame: 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
Doses of pain medications
Time frame: 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
Time frame: 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 at baseline
Time frame: 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 preoperatively
Time frame: 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 understanding of surgery 2 weeks post-operative
Time frame: 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 3 months post-operative
Time frame: 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 understanding of surgery 6 months post-operative
Time frame: 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
Patient pain level expectation at baseline
Time frame: 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 expectation preoperatively
Time frame: 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.
Patient pain level 2 weeks post-operatively
Time frame: 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.
Patient pain level 3 months post-operatively
Time frame: 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 pain level 6 months post-operatively
Time frame: 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 at baseline
Time frame: 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
Confidence in surgeon preoperatively
Time frame: 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
Time frame: 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
Confidence in surgeon 3 months post-operatively
Time frame: 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
Confidence in surgeon 6 months post-operatively
Time frame: 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 at baseline
Time frame: 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 visit satisfaction level preoperatively
Time frame: 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 at baseline
Time frame: 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 satisfaction level with the surgical explanation preoperatively
Time frame: 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 2 weeks post-operatively
Time frame: 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
Time frame: 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 postoperative visit satisfaction level 6 months post-operatively
Time frame: 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 surgery satisfaction level 2 weeks post-operatively
Time frame: 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 visit satisfaction level 3 months post-operatively
Time frame: 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 surgery satisfaction level 6 months post-operatively
Time frame: 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
3 secondary outcomes
Patient referral rates
Time frame: Patient referral rates will be assessed up to 6 months post-operatively
Patient retention rates
Time frame: Patient retention rates will be assessed up to 6 months post-operatively
Patient preference on the type of preoperative counseling received for the AR-specific participants
Time frame: This will be assessed immediately following preoperatiive counseling within the treatment group
Results and safety
The study was stopped early (reason given: Poor recruitment and subsequently untenable study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 27906757Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
- Background: PubMed 29631869Collins MK, Ding VY, Ball RL, Dolce DL, Henderson JM, Halpern CH. Novel application of virtual reality in patient engagement for deep brain stimulation: A pilot study. Brain Stimul. 2018 Jul-Aug;11(4):935-937. doi: 10.1016/j.brs.2018.03.012. Epub 2018 Mar 15. No abstract available.
- Background: PubMed 30471460Eastwood D, Manson N, Bigney E, Darling M, Richardson E, Paixao R, Underwood T, Ellis K, Abraham E. Improving postoperative patient reported benefits and satisfaction following spinal fusion with a single preoperative education session. Spine J. 2019 May;19(5):840-845. doi: 10.1016/j.spinee.2018.11.010. Epub 2018 Nov 22.
- Background: PubMed 31786547Panesar SS, Magnetta M, Mukherjee D, Abhinav K, Branstetter BF, Gardner PA, Iv M, Fernandez-Miranda JC. Patient-specific 3-dimensionally printed models for neurosurgical planning and education. Neurosurg Focus. 2019 Dec 1;47(6):E12. doi: 10.3171/2019.9.FOCUS19511.
- Background: PubMed 35442936Rampersaud YR, Canizares M, Perruccio AV, Abraham E, Bailey CS, Christie SD, Evaniew N, Finkelstein JA, Glennie RA, Johnson MG, Nataraj A, Paquet J, Phan P, Weber MH, Thomas K, Manson N, Hall H, Fisher CG. Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. Neurosurgery. 2022 Jul 1;91(1):173-181. doi: 10.1227/neu.0000000000001981. Epub 2022 Apr 22.
- Background: PubMed 33203047Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
- Background: PubMed 31113688Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
- Background: PubMed 36921342Delgado CA, McCullers MR, Bloom SW. Evaluating the Efficacy of Surgical Consent. Am Surg. 2023 Aug;89(8):3433-3437. doi: 10.1177/00031348231161702. Epub 2023 Mar 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Andrews, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Enhanced Preoperative Counseling and Standard preoperative counseling in people with Anterior Cervical Discectomy and Fusion, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment and subsequently untenable study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling (time frame: The APAIS is to be completed within 24 hours after preoperative counseling). The study lists 43 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340672, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.