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

NCT07443111 | Not Yet Recruiting

• 1 other identifier: BVU-20260206-VR
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lumbar Disc Herniation; Preoperative Anxiety

Keywords

Virtual Reality; Lumbar Disc Herniation; Preoperative Anxiety; Salivary Cortisol; Randomized Controlled Trial; Nursing Intervention

Outcome Measures

Primary Outcomes (2)

• Change in Surgical Anxiety Level (SAQ Total Score)

  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).

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

• Change in Salivary Cortisol Level

  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).

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

Study Arms (2)

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.

Behavioral: Virtual Reality-Based Preoperative Education

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.

Behavioral: Routine Preoperative Education

Interventions

Virtual Reality-Based Preoperative Education BEHAVIORAL

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

Virtual Reality-Based Preoperative Education

Routine Preoperative Education BEHAVIORAL

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

Routine Preoperative Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Related Publications (1)

• 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 SP, Elahi A, Tabari F, Haghani S, Dehghan MF, Navidhamidi M. Evaluating the effect of preoperative provision of information on salivary cortisol in patients undergoing breast cancer surgery: A randomized controlled study. Journal of PeriAnesthesia Nursing. 2023;38:63-68. Topçu SY, Soydaş D, Özkan ZK, Ünver S, Orğan EM, Fındık ÜY. Turkish validity and reliability study of the Surgical Anxiety Questionnaire for adult patients. Journal of PeriAnesthesia Nursing. 2023;38:127-133.

  BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• NURGÜL ARPAG, Assistant Professor,PhD, RN

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurgül Arpag, Assistant Professor, PhD, RN

CONTACT

+90 212 401 26 00; nurgul.arpag@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: February 27, 2026
• Primary Completion: April 27, 2026
• Study Completion: May 27, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02