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Набор по приглашению 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

Без фазы С лечением Chronic Venous Insufficiency, CVI

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VR (VR-Control).
Кому может быть актуально
Состояния в реестре: Chronic Venous Insufficiency, CVI. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство VR (VR-Control)
    Immersive Virtual reality

Первичные конечные точки

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

Критерии участия

Критерии включения

  • adults people scheduled to EVLA under local anesthesia and signed for VR interventiion.

Критерии исключения

  • exclusion of epilepsy, severe motion sickness, previous severe cybersickness

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Польша · 1 центр
  • Bydgoszcz Univ of Science and Technology — Bydgoszcz

Идентификаторы

NCT: NCT07624929 · VR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗