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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 (EVLA+VR)

30. Mai 2026 aktualisiert von: Katarzyna Sierakowska, Bydgoszcz University of Science and Technology
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

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Polen
      • Bydgoszcz, Polen, 85-796
        • Bydgoszcz Univ of Science and Technology

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Adult patients, scheduled to EVLA procedure under local anesthesia.
exclusion of epilepsy, severe motion sickness, previous severe cybersickness
Gerät: VR (VR-Control)
Immersive Virtual reality

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Procedural anxiety
Zeitfenster: 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.
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
Zeitfenster: 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.
Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).
Heart Rate
Zeitfenster: 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.
Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
Cybersickness severity
Zeitfenster: 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,
Day 1- after completing the surgical procedure.
Patient satisfaction
Zeitfenster: 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.
From enrollment to the end of treatment at 8 weeks"
Systolic blood pressure
Zeitfenster: 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.
From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
Diastolic blood pressure
Zeitfenster: 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.
From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
Oxygen saturation
Zeitfenster: 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.
From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bydgoszcz University of Science and Technology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juni 2026

Primärer Abschluss (Geschätzt)

10. Mai 2028

Studienabschluss (Geschätzt)

10. September 2028

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • VR

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

No plan to share individual participant data (IPD) to other researchers. Aggregated study results will be published in a peer-reviewed journal.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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