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

NCT07624929 | Enrolling By Invitation

• 1 other identifier: VR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Venous Insufficiency, CVI

Keywords

EVLA; VR

Outcome Measures

Primary Outcomes (8)

• Procedural anxiety

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

  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).

• Level of procedural pain

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

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

• Heart Rate

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

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

• Cybersickness severity

  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,

  Day 1- after completing the surgical procedure.

• Patient satisfaction

  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.

  From enrollment to the end of treatment at 8 weeks"

• Systolic blood pressure

  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.

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

• Diastolic blood pressure

  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.

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

• Oxygen saturation

  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.

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

Study Arms (1)

Adult patients, scheduled to EVLA procedure under local anesthesia.

EXPERIMENTAL

exclusion of epilepsy, severe motion sickness, previous severe cybersickness

Device: VR (VR-Control)

Interventions

VR (VR-Control) DEVICE

Immersive Virtual reality

Adult patients, scheduled to EVLA procedure under local anesthesia.

Eligibility Criteria

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

You may qualify if:

• adults people scheduled to EVLA under local anesthesia and signed for VR interventiion.

Sponsors & Collaborators

• Bydgoszcz University of Science and Technology: lead

Study Sites (1)

Bydgoszcz Univ of Science and Technology

Bydgoszcz, 85-796, Poland

Location

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: June 3, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): May 10, 2028
• Study Completion (Estimated): September 10, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)