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临床试验/NCT07624929
NCT07624929Enrolling By Invitation不适用

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

Bydgoszcz University of Science and Technology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Adult patients, scheduled to EVLA procedure under local anesthesia.

Experimental

exclusion of epilepsy, severe motion sickness, previous severe cybersickness

干预措施: VR (VR-Control) (Device)

研究者

发起方
Bydgoszcz University of Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katarzyna Sierakowska

University Professor

Bydgoszcz University of Science and Technology

研究点 (1)

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