[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627013":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Bezmialem Vakif University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality-Based Preoperative Education","EXPERIMENTAL","Participants in this arm receive virtual reality-based preoperative education using a head-mounted VR device on the day before lumbar disc surgery. The VR content provides structured information about the surgical process, operating room environment, anesthesia, and postoperative expectations. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response.",[13],"Behavioral: Virtual Reality-Based Preoperative Education",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Preoperative Education","ACTIVE_COMPARATOR","Participants in this arm receive routine preoperative education provided according to the hospital's standard clinical practice before lumbar disc surgery. The education includes verbal information about the surgical procedure, anesthesia, and postoperative care. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response.",[19],"Behavioral: Routine Preoperative Education",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Virtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery.",[15],[30],{"name":31,"affiliation":5,"role":32},"NURGÜL ARPAG, Assistant Professor,PhD, RN","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Nurgül Arpag, Assistant Professor, PhD, RN","CONTACT","+90 212 401 26 00","4608","nurgul.arpag@bezmialem.edu.tr",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100627013","comparison-of-virtual-reality-based-and-routine-preoperative-education-on-surgical-anxiety-and-salivary-cortisol-100627013",false,"NCT07443111","Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol","Comparative Evaluation of the Effect of Virtual Reality-Based Preoperative Education on Surgical Anxiety Using Psychometric Measures and Salivary Cortisol: A Randomized Controlled Pilot Trial","Inclusion Criteria:\n\nAge between 18 and 65 years\n\nHospitalized patients scheduled for elective lumbar disc herniation surgery in the preoperative period\n\nAmerican Society of Anesthesiologists (ASA) physical status I-III\n\nAble to read and understand Turkish and be literate\n\nSufficient cognitive capacity to understand the informed consent form (no advanced dementia, severe aphasia, impaired consciousness, or neurological\u002Fpsychiatric condition interfering with communication)\n\nWilling to complete the State Anxiety Inventory - State form (STAI-S) for surgical anxiety assessment and to provide a saliva sample using a non-invasive method\n\nNo severe visual impairment that would prevent the use of a virtual reality headset (visual impairments correctable with glasses or contact lenses are acceptable)\n\nProvision of written and verbal informed consent\n\nExclusion Criteria:\n\nPresence of an emergency or urgent neurosurgical indication (e.g., traumatic acute subdural hematoma, acute intracranial hemorrhage with herniation signs)\n\nHistory of diagnosed epilepsy, particularly photosensitive epilepsy\n\nSevere cognitive impairment, severe aphasia, lack of cooperation, or altered level of consciousness\n\nHistory of psychiatric hospitalization within the last 6 months due to severe psychiatric disorders such as psychotic disorder, bipolar disorder, or severe major depressive disorder\n\nChronic systemic steroid use or endocrine disorders significantly affecting adrenal cortex function (e.g., Cushing syndrome, Addison's disease)\n\nUntreated severe thyroid disease that may affect cortisol metabolism\n\nHistory of severe vertigo or vestibular disorders with prior intolerance to VR-like visual stimuli\n\nSevere visual impairment not correctable with glasses or contact lenses that would prevent adequate perception of VR content\n\nInability to complete the VR session due to nausea, dizziness, or similar symptoms during headset use (in such cases, the intervention will be discontinued and the participant will be withdrawn from the study)\n\nSevere oral lesions, active serious oral infection, or significant salivary gland pathology interfering with saliva sampling\n\nKnown pregnancy or suspected pregnancy\n\nParticipation in another randomized controlled trial or VR-based intervention within the last 3 months\n\nWithdrawal of consent during the study or cancellation\u002Fpostponement of the scheduled surgical procedure","ALL","18 Years","65 Years",{"count":53,"type":54},56,"ESTIMATED","INTERVENTIONAL",[57],"NA","This randomized controlled pilot study aims to compare the effects of virtual reality-based preoperative education and routine preoperative education on surgical anxiety in patients undergoing lumbar disc surgery. In addition to evaluating psychological outcomes, the study will also compare psychometric anxiety assessments with a biological stress marker, salivary cortisol, to examine the relationship between subjective and physiological stress responses.\n\nPreoperative anxiety is common among surgical patients and may negatively influence both emotional well-being and physiological stress regulation. Virtual reality-based education may provide a more immersive and engaging learning experience compared to routine education, potentially reducing anxiety levels.\n\nParticipants will be randomly assigned to either a virtual reality-based education group or a routine preoperative education group. Surgical anxiety will be assessed using validated psychometric measurement tools, and physiological stress response will be evaluated through salivary cortisol analysis. The study will further explore the concordance between psychometric findings and biological stress indicators.\n\nThe results may contribute to the development of innovative, evidence-based nursing interventions and provide insight into the relationship between psychological and biological indicators of preoperative anxiety.",[60,61],"Lumbar Disc Herniation","Preoperative Anxiety",[63,60,61,64,65,66],"Virtual Reality","Salivary Cortisol","Randomized Controlled Trial","Nursing Intervention","NOT_YET_RECRUITING","2026-02-25",{"date":70,"type":71},"2026-03-02","ACTUAL",{"date":73,"type":54},"2026-02-27",{"date":75,"type":54},"2026-05-27",{"name":5,"class":6}]