The Use of Immersive Virtual Reality as a Method of Treating Anxiety and Procedural Pain During E… (NCT07624929) | Clinical Trial Compass
By InvitationNot Applicable
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
Poland100 participantsStarted 2026-06-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses immersive virtual reality during the EVLA procedure to help with anxiety and pain — how does that actually work in practice, and would it change anything about how my procedure is performed or how the tumescent anesthesia is given?
2The trial is measuring something called 'cybersickness' as one of its outcomes — what is that, and is there a risk that the VR headset could make me feel worse during an already uncomfortable procedure?
3Since this study is enrolling by invitation only, what would make my doctor consider me a good or poor candidate to be invited, and are there any characteristics — like claustrophobia or motion sensitivity — that might make VR a bad fit for me specifically?
4The trial is in a non-standard phase focused on measuring things like heart rate, blood pressure, and oxygen saturation alongside anxiety and pain — does that mean the main goal is to understand safety and feasibility of VR during EVLA, rather than proving it definitely helps?
5If I'm not part of this trial, is there anything else available to help manage anxiety and pain during EVLA under tumescent anesthesia, so I can compare what I might be giving up or gaining by participating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural anxiety
Timeframe: 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).
2
Level of procedural pain
Timeframe: Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).
3
Heart Rate
Timeframe: Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
4
Cybersickness severity
Timeframe: Day 1- after completing the surgical procedure.
5
Patient satisfaction
Timeframe: From enrollment to the end of treatment at 8 weeks"
6
Systolic blood pressure
Timeframe: From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
7
Diastolic blood pressure
Trial details
NCT IDNCT07624929
SponsorBydgoszcz University of Science and Technology