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Enrolling by invitation NCT07624929

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

No phase Interventional Chronic Venous Insufficiency, CVI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR (VR-Control).
Who it may be relevant to
Registry conditions: Chronic Venous Insufficiency, CVI. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device VR (VR-Control)
    Immersive Virtual reality

Primary outcome measures

  • 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).]
  • Level of procedural pain [Time frame: Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).]
  • Heart Rate [Time frame: Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.]
  • Cybersickness severity [Time frame: Day 1- after completing the surgical procedure.]
  • Patient satisfaction [Time frame: From enrollment to the end of treatment at 8 weeks"]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Poland · 1 center
  • Bydgoszcz Univ of Science and Technology — Bydgoszcz

Identifiers

NCT: NCT07624929 · VR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗