The Use of Immersive Virtual Reality as a Method of Treating Anxiety and Procedural Pain During Endovenous Laser Ablation (EVLA) of Lower Varicose Veins Under Tumescent Anesthesia

Primary outcomes

1. Procedural anxiety

   Time frame: Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2) to the end of treatment at 8 weeks (3).

   Visual Analogue Scale (VAS), 0-10 points, 0-no anxiety, 10-max anxiety level. Higher scores mean worse outcome.

2. Level of procedural pain

   Time frame: Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).

   Visual Analogue Scale (VAS), 0-10, 0- no pain, 10-max pain ever. Higher scores mean a worse outcome.

3. Heart Rate

   Time frame: Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.

   Heart Rate is the number of times a heart beats in one minute (bpm). Normal heart rate is 60-100 bpm.

4. Cybersickness severity

   Time frame: Day 1- after completing the surgical procedure.

   SSQ The Simulator Sickness Questionnaire is the standard tool used to measure cybersickness. Patients rate 16 symptoms on a scale from 0 to 3- no, moderate, severe. These scores are mathematically weighted and aggreagated into a total scowe ranges 0-48 points.

   0-5 severity level negligible, no symptoms, the VR experience is perfectly comfortable.

   5-10 severity evel minimal, mild discomfort 10-15 significant, definitive sensory mismatch, patients may experiance slight nausea or disorientation 15-20 concerning, noticeable sickness, the experiance is moderately uncomfortable more than 20- high, the VR application causes severe discomfort and requires a redesign to reduce visual motion. Higher scores mean a worse outcome.

   The 16 symptoms are mapped into 3 subscales: nausea or stomach awareness, occulomotor- eye strain and difficulty focusing, disorientation- dizziness, vertigo,

5. Patient satisfaction

   Time frame: From enrollment to the end of treatment at 8 weeks"

   SUS- usability questionnaire is the system usability scale, which measures the feeling of usability of the users when using computer systems, navigate patient portals, telemedicine platforms, or self-management apps. A reliable tool that measures how easy to use, complex, or efficient a patient or user finds a digital health application.

   It is composed of 10 questions with a five-point Likert attitude scale (from strongly disagree to strongly agree), typically ranging from 1 ("Not at all") to 5 ("Very much").

   Calculation: Scores range from 0 to 100. A score above 68 is generally considered above-average usability.

6. Systolic blood pressure

   Time frame: From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.

   Systolic blood pressure measures the maximum pressure of blood exerts against your artery walls when your heart beats and pumps blood out to the body.

   Key Ranges (in mm Hg) Normal: Below 120, Elevated: 120-129, Hypertension (High Blood Pressure): 130 or higher.

7. Diastolic blood pressure

   Time frame: From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.

   Diastolic blood pressure is the bottom (lower) number in a blood pressure reading. It measures the minimum pressure exerted against artery walls when a heart muscle is resting and refilling with blood between beats. A standard blood pressure reading is measured in millimeters of mercury (mm Hg). According to standard cardiovascular guidelines, blood pressure is categorized by the following diastolic ranges:Normal: Less than (80) mm Hg.Elevated: Less than (80) mm Hg (with systolic between (120-129)).Hypertension Stage 1: (80-89) mm Hg.Hypertension Stage 2: (90) mm Hg or higher.Hypertensive Crisis: Higher than (120) mm Hg.

8. Oxygen saturation

   Time frame: From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.

   Oxygen saturation measured by Pulse Oximetry Sp02 measures the percentage of hemoglobin in red blood cells that is actively carrying oxygen. It indicates how effectively is blood transports oxygen from the lungs throughout the body.Typical Ranges & Interpretation Normal Range: 95% to 100% for a healthy adult. Low (Hypoxemia): Values below 90% are considered low and typically require external oxygen supplementation or medical evaluation.