Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Sa… (NCT07443111) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol
56 participantsStarted 2026-02-27
Plain-language summary
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.
Preoperative 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.
Participants 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.
The 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age between 18 and 65 years
Hospitalized patients scheduled for elective lumbar disc herniation surgery in the preoperative period
American Society of Anesthesiologists (ASA) physical status I-III
Able to read and understand Turkish and be literate
Sufficient cognitive capacity to understand the informed consent form (no advanced dementia, severe aphasia, impaired consciousness, or neurological/psychiatric condition interfering with communication)
Willing 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
No severe visual impairment that would prevent the use of a virtual reality headset (visual impairments correctable with glasses or contact lenses are acceptable)
Provision of written and verbal informed consent
Exclusion Criteria:
Presence of an emergency or urgent neurosurgical indication (e.g., traumatic acute subdural hematoma, acute intracranial hemorrhage with herniation signs)
History of diagnosed epilepsy, particularly photosensitive epilepsy
Severe cognitive impairment, severe aphasia, lack of cooperation, or altered level of consciousness
History of psychiatric hospitalization within the last 6 months due to severe psychiatric disorders such as psychotic disorder, bipolar disorder, or severe major depressive disorder
Chronic systemic steroid use or endocrine disorders significantly affecting adrenal cortex function (e.g., Cushing s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Surgical Anxiety Level (SAQ Total Score)
Timeframe: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
2
Change in Salivary Cortisol Level
Timeframe: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)