Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol

Official title

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

Overview

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.

Detailed description

This randomized controlled pilot trial is designed to evaluate the effectiveness of virtual reality-based preoperative education compared to routine preoperative education in adult patients scheduled for elective lumbar disc surgery. In addition to comparing anxiety levels between groups, the study aims to examine the relationship between psychometric assessments of surgical anxiety and the biological stress response measured by salivary cortisol.

Eligible participants will be adult patients undergoing elective lumbar disc surgery who meet the inclusion criteria and provide informed consent. Participants will be randomly allocated to one of two groups using a structured randomization process to ensure balanced distribution.

The intervention group will receive a structured virtual reality-based preoperative education session delivered through immersive technology explaining the surgical procedure, operating room environment, and perioperative process. The control group will receive routine preoperative education provided according to standard clinical practice. All participants will continue to receive standard medical and nursing care.

Data collection will be performed at predefined time points. Baseline measurements (T0) will be obtained prior to the educational intervention. Post-intervention anxiety assessments and salivary cortisol sampling (T1) will be conducted during the preoperative period before surgery. Surgical anxiety will be assessed using validated psychometric measurement instruments. Salivary cortisol levels will be analyzed as an objective indicator of physiological stress response.

The study will evaluate between-group differences in anxiety scores and cortisol levels. Additionally, the concordance and relationship between subjective psychometric measures and biological stress markers will be analyzed.

As a pilot study, the primary objectives include assessing feasibility, preliminary effectiveness, and methodological suitability for a future large-scale randomized trial. The findings may contribute to the development of evidence-based, technology-supported nursing interventions aimed at reducing preoperative anxiety and improving perioperative patient outcomes.

Interventions

• Behavioral Virtual Reality-Based Preoperative Education
  Virtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery.
• Behavioral Routine Preoperative Education
  Standard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery.

Primary outcome measures

• Change in Surgical Anxiety Level (SAQ Total Score) [Time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)]
• Change in Salivary Cortisol Level [Time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)]

Eligibility criteria

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 syndrome, Addison's disease)

Untreated severe thyroid disease that may affect cortisol metabolism

History of severe vertigo or vestibular disorders with prior intolerance to VR-like visual stimuli

Severe visual impairment not correctable with glasses or contact lenses that would prevent adequate perception of VR content

Inability 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)

Severe oral lesions, active serious oral infection, or significant salivary gland pathology interfering with saliva sampling

Known pregnancy or suspected pregnancy

Participation in another randomized controlled trial or VR-based intervention within the last 3 months

Withdrawal of consent during the study or cancellation/postponement of the scheduled surgical procedure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Asiri S, Currie J, Duff J, Guilhermino M. Effectiveness of virtual reality interventions for perioperative anxiety in adults: A systematic review with meta-analysis. Journal of Clinical Nursing. 2025;34:3539-3559. Moharam SA, et al. Effect of virtual reality on perioperative anxiety, stress and pain in total hip arthroplasty: A randomized controlled trial. BMC Anesthesiology. 2025;25:446. Karamad

Identifiers

NCT: NCT07443111 · BVU-20260206-VR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗