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NCT Number: NCT07443111

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality-Based Preoperative Education

Behavioral

Virtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery.

Routine Preoperative Education

Behavioral

Standard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery.

Primary outcomes

  1. 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 preoperative anxiety measured by the Surgical Anxiety Questionnaire (SAQ) total score between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).

  2. Change in Salivary Cortisol Level

    Time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)

    Change in physiological stress response measured by salivary cortisol levels between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).

Study contacts

Contact information is provided by the study sponsor or research team.

Nurgül Arpag, Assistant Professor, PhD, RN

CONTACT

[email protected]

+90 212 401 26 00 ext. 4608

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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