Chronic Venous Insufficiency, CVIEVLA+VRNCT07624929
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
A study of Chronic Venous Insufficiency, CVI, run by Bydgoszcz University of Science and Technology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, CVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jun 2026to 10 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults people scheduled to EVLA under local anesthesia and signed for VR interventiion.
Who cannot join
- exclusion of epilepsy, severe motion sickness, previous severe cybersickness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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.
- Conditions
- Chronic Venous Insufficiency, CVI
- Being tested
- VR (VR-Control)
- Keywords
- EVLA, VR
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR (VR-Control)Device
Immersive Virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Adult patients, scheduled to EVLA procedure under local anesthesia. | Experimental | exclusion of epilepsy, severe motion sickness, previous severe cybersickness Receives: Device: VR (VR-Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural anxiety
Visual Analogue Scale (VAS), 0-10 points, 0-no anxiety, 10-max anxiety level. Higher scores mean worse outcome.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 May 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency, CVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bydgoszcz University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Sierakowska, Bydgoszcz University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624929
- Sponsor's protocol ID
- VR
- Acronym
- EVLA+VR
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD) to other researchers. Aggregated study results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07624929
- Acronym / sponsor ID
- EVLA+VR / VR
- Conditions
- Chronic Venous Insufficiency, CVI
- Keywords
- EVLA, VR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bydgoszcz University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 May 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients, scheduled to EVLA procedure under local anesthesia. | Experimental | Device: VR (VR-Control)exclusion of epilepsy, severe motion sickness, previous severe cybersickness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults people scheduled to EVLA under local anesthesia and signed for VR interventiion.
Key exclusion criteria (1 listed)
- exclusion of epilepsy, severe motion sickness, previous severe cybersickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR (VR-Control)Immersive Virtual reality | Device | Adult patients, scheduled to EVLA procedure under local anesthesia. |
Primary outcome
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.
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.
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.
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,
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) to other researchers. Aggregated study results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Venous Insufficiency, CVI, run by Bydgoszcz University of Science and Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.