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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Bydgoszcz、ポーランド、85-796
- Bydgoszcz Univ of Science and Technology
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Adult patients, scheduled to EVLA procedure under local anesthesia.
exclusion of epilepsy, severe motion sickness, previous severe cybersickness
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Immersive Virtual reality
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Procedural anxiety
時間枠：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).
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Visual Analogue Scale (VAS), 0-10 points, 0-no anxiety, 10-max anxiety level.
Higher scores mean worse outcome.
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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).
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Level of procedural pain
時間枠：Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).
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Visual Analogue Scale (VAS), 0-10, 0- no pain, 10-max pain ever.
Higher scores mean a worse outcome.
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Baseline (0), at the beginning of surgical procedure (1), at the end of surgical procedure (2).
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Heart Rate
時間枠：Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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Heart Rate is the number of times a heart beats in one minute (bpm).
Normal heart rate is 60-100 bpm.
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Baseline, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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Cybersickness severity
時間枠：Day 1- after completing the surgical procedure.
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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.
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Patient satisfaction
時間枠：From enrollment to the end of treatment at 8 weeks"
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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"
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Systolic blood pressure
時間枠：From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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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.
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Diastolic blood pressure
時間枠：From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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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.
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From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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Oxygen saturation
時間枠：From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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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.
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From enrollment, at the beginning of surgical procedure and every 5 minutes during EVLA and in the end of surgical procedure.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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IPD プランの説明
医薬品およびデバイス情報、研究文書
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