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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Change in Surgical Anxiety Level (SAQ Total Score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality-Based Preoperative Education
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.
干预措施: Virtual Reality-Based Preoperative Education (Behavioral)
Routine Preoperative Education
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.
干预措施: Routine Preoperative Education (Behavioral)
结局指标
主要结局
Change in Surgical Anxiety Level (SAQ Total Score)
时间窗: 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).
Change in Salivary Cortisol Level
时间窗: 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).
次要结局
未报告次要终点