Chronic Venous Insufficiency, CVI
Conditions
Keywords
EVLA, VR
Brief summary
This is a prospective, single-arm, pre-post interventional study designed to evaluate the feasibility, safety, and impact of immersive virtual reality (VR) as an adjunct to tumescent local anesthesia during endovenous laser ablation (EVLA) for varicose veins / chronic venous insufficiency. All eligible and consenting participants will receive the same intervention (immersive VR during the entire EVLA procedure). There is no randomization, no control group, and no allocation to different arms. Each participant serves as their own control through before-and-after comparisons
Detailed description
This prospective single-arm interventional study with a pre-post design aims to assess the effect of immersive virtual reality (VR) on procedural anxiety, pain perception, cybersickness, sense of presence, usability, and overall patient satisfaction during ambulatory endovenous laser ablation (EVLA) performed under tumescent local anesthesia (TLA). All consenting adult patients scheduled for unilateral or bilateral EVLA of the great saphenous vein (GSV), small saphenous vein (SSV), or accessory veins due to symptomatic chronic venous insufficiency (CEAP C2-C6) will be enrolled. There is no control group: every participant who provides informed consent will receive immersive VR (using a head-mounted display with relaxing/immersive nature-based content) starting 5-10 minutes before tumescent infiltration and continuing throughout the procedure (\ 30-60 minutes). Key outcome measures will be collected at multiple time points: Baseline (pre-procedure): hemodynamic parameters, saturation, technology experience, baseline anxiety and pain (VAS / NRS), every 5 minutes during the procedure and right after the surgical procedure, cybersickness (SSQ), satisfaction and any adverse events. Technology-Focused Objective • To evaluate usability and tolerability of VR technology in a real clinical setting, including: * comfort of use during a medical procedure * interaction with the device during limited mobility * feasibility of VR integration into procedural workflow Follow-up (4-6 weeks): delayed pain, satisfaction, technology experience, and adverse events. The primary endpoint is the change in procedural anxiety (VAS) from pre- to post-procedure. Secondary endpoints include change in pain (NRS) and hemodynamic profile, cybersickness severity, presence scores, usability, patient satisfaction, and safety profile of VR in this setting.
Interventions
DEVICEVR (VR-Control)
Immersive Virtual reality
Sponsors
Bydgoszcz University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults people scheduled to EVLA under local anesthesia and signed for VR interventiion.
Exclusion criteria
* exclusion of epilepsy, severe motion sickness, previous severe cybersickness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural anxiety | 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. |
| Level of procedural pain | 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. |
| Heart Rate | 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. |
| Cybersickness severity | 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, |
| Patient satisfaction | 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. |
| Systolic blood pressure | 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. |
| Diastolic blood pressure | 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. |
| Oxygen saturation | 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. |
Countries
Poland
Outcome results
None listed