Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 maggio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Adult patients, scheduled to EVLA procedure under local anesthesia.
exclusion of epilepsy, severe motion sickness, previous severe cybersickness
Dispositivo: VR (VR-Control)
Immersive Virtual reality

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Procedural anxiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bydgoszcz University of Science and Technology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 giugno 2026

Completamento primario (Stimato)

10 maggio 2028

Completamento dello studio (Stimato)

10 settembre 2028

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VR

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su VR (VR-Control)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Trinidad & Tobago

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi