protocolSection identificationModule nctId: NCT06340672, orgStudyIdInfo id: STUDY24010034, briefTitle: The Effect of AR in Patient Pre-operative Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: 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 older 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., conditionsModule conditions: Anterior Cervical Discectomy and Fusion, conditions: Transforaminal Lumbar Interbody Fusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Augmented Reality Enhanced Preoperative Counseling, interventions name: Standard preoperative counseling, outcomesModule primaryOutcomes measure: Amsterdam Preoperative Anxiety and Information Score (APAIS) survey, primaryOutcomes measure: Simulator Sickness Questionnaire (SSQ), primaryOutcomes measure: Evaluation of the Experience of General Anesthesia (EVAN-G) Survey, primaryOutcomes measure: Time of preoperatively patient counseling, primaryOutcomes measure: Degree of knowledge acquisition questionnaire at baseline, primaryOutcomes measure: Degree of knowledge acquisition questionnaire 2 weeks post-operative, primaryOutcomes measure: Degree of knowledge acquisition questionnaire 3 months post-operative, primaryOutcomes measure: Degree of knowledge acquisition questionnaire 6 months post-operative, primaryOutcomes measure: Participant age, primaryOutcomes measure: Participant gender, primaryOutcomes measure: Participant's indication for surgery, primaryOutcomes measure: Participant education, primaryOutcomes measure: Participant's past surgeries, primaryOutcomes measure: Names of pain medications, primaryOutcomes measure: Doses of pain medications, primaryOutcomes measure: Prior experience with simulated environments, primaryOutcomes measure: Patient understanding of surgery at baseline, primaryOutcomes measure: Patient understanding of surgery 2 weeks post-operative, primaryOutcomes measure: Patient understanding of surgery 3 months post-operative, primaryOutcomes measure: Patient understanding of surgery 6 months post-operative, primaryOutcomes measure: Patient pain level at baseline, primaryOutcomes measure: Patient pain level 2 weeks post-operatively, primaryOutcomes measure: Patient pain level 3 months post-operatively, primaryOutcomes measure: Patient pain level 6 months post-operatively, primaryOutcomes measure: Confidence in surgeon at baseline, primaryOutcomes measure: Confidence in surgeon 2 weeks post-operatively, primaryOutcomes measure: Confidence in surgeon 3 months post-operatively, primaryOutcomes measure: Confidence in surgeon 6 months post-operatively, primaryOutcomes measure: Patient preoperative visit satisfaction level, primaryOutcomes measure: Patient satisfaction level with the surgical explanation at baseline, primaryOutcomes measure: Patient postoperative visit satisfaction level 2 weeks post-operatively, primaryOutcomes measure: Patient surgery satisfaction level 2 weeks post-operatively, primaryOutcomes measure: Patient postoperative visit satisfaction level 3 months post-operatively, primaryOutcomes measure: Patient surgery visit satisfaction level 3 months post-operatively, primaryOutcomes measure: Patient postoperative visit satisfaction level 6 months post-operatively, primaryOutcomes measure: Patient surgery satisfaction level 6 months post-operatively, secondaryOutcomes measure: Patient referral rates, secondaryOutcomes measure: Patient retention rates, secondaryOutcomes measure: Patient preference on the type of pre-operative counseling received for the AR-specific participants, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Edward Andrews, MD, role: CONTACT, phone: 412-232-5666, email: andrewse2@upmc.edu, contacts name: Edward Andrews, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False