Mindfulness Intervention on Minimally Invasive Vascular Surgery

This is a single-center, prospective, open-label, parallel-group randomized controlled trial involving 160 adults undergoing elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia. After eligibility is confirmed and written informed consent is obtained, participants will complete all prespecified baseline assessments before group allocation. Participants will then be randomly assigned in a 1:1 ratio to the VR-based mindfulness intervention group or the control group using block randomization with a fixed block size of 4. The randomization sequence will be generated using SAS version 9.4, and allocation will be concealed using sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessments, a trained nurse will open the next envelope in numerical order and assign the participant according to the allocation indicated inside the envelope.

Participants in the intervention group will receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area. At the start of surgery, they will begin an intraoperative VR-based mindfulness session lasting 25 minutes. After completion of the first 25-minute session and the corresponding intraoperative assessment, the VR-based mindfulness intervention will be resumed and repeated in 25-minute sessions until the end of surgery. Participants in the control group will receive routine psychological care before and during surgery.

State anxiety will be assessed approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and at the end of surgery. The 25-minute intraoperative assessment corresponds to completion of the first 25-minute VR-based mindfulness session in the intervention group, with participants in the control group assessed at the corresponding time point. Additional outcomes include pain intensity, blood pressure, heart rate, fatigue, sleep quality, patient satisfaction, and duration of surgery.

• VR-Based Mindfulness Intervention (Behavioral): The VR-based mindfulness intervention will be delivered in two perioperative stages on the day of surgery. Approximately 30 minutes before surgery, participants assigned to the intervention group will be transferred to a dedicated room in the preoperative waiting area. A mindfulness-trained waiting-area nurse will assist participants in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. At the start of surgery, another mindfulness-trained research nurse will assist participants in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery.

Primary outcomes

• State-Trait Anxiety Inventory-State Subscale (STAI-State) [Approximately 30 min before surgery, immediately before surgery, 25 min after surgery starts, and at surgery end. The 25-min assessment follows the first VR mindfulness session in the intervention group; controls are assessed at the same time]: The STAI-State is a 20-item self-report measure of state anxiety. Each item is rated on a 4-point scale, yielding a total score ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.

Secondary outcomes

• Pain Intensity (Numeric Rating Scale, NRS) [Approximately 30 min before surgery and at surgery end, when maximum intraoperative pain and current pain intensity will be assessed.]: Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. At the end of surgery, participants will report both their highest pain experienced during surgery and their current pain intensity.
• blood pressure [Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.]: Systolic and diastolic blood pressure will be measured in mmHg using the perioperative patient monitor.
• Fatigue (Brief Fatigue Inventory, BFI) [Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1, assessing fatigue related to the day of surgery.]: Fatigue will be assessed using the 9-item Brief Fatigue Inventory (BFI). Each item is scored from 0 to 10, with higher scores indicating greater fatigue.
• Sleep Quality (Leeds Sleep Evaluation Questionnaire, LSEQ) [Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1.]: Sleep quality will be assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), which includes 10 items across four domains: getting to sleep, sleep quality, awakening, and post-awakening state. Each item is rated on a 100-mm visual analogue scale.
• Satisfaction scale [24 hours postoperatively (Day 1)]: Each dimension is scored using a 5-point Likert scale ranging from " never" (1 point) to "very frequently or always" (5 points).Higher scores indicate greater patient satisfaction
• heart rate [Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.]: Heart rate will be measured in beats per minute (bpm) using the perioperative patient monitor. Intraoperative values will be monitored every 5 minutes and automatically recorded by the monitoring system.

Sex: All, ages: 18 Years to any

Inclusion Criteria

1. Age ≥18 years.
2. American Society of Anesthesiologists (ASA) physical status I-III.
3. Clinically and imaging-confirmed superficial lower-extremity varicose veins with venous insufficiency and great saphenous vein involvement, with CEAP class C3-C5.
4. Scheduled for elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia.
5. Willing and able to provide written informed consent.
6. Able to complete the study procedures and follow-up assessments.
7. No other severe systemic disease or surgical contraindication that may compromise surgical safety or materially interfere with interpretation of the study outcomes.

Exclusion Criteria

1. Cognitive impairment according to the prespecified study screening criterion (MMSE score ≤26).
2. Unable to wear or use the VR device, including because of blindness or deafness.
3. Previous history of the same type of varicose vein surgery.
4. Acute or chronic pain unrelated to peripheral vascular disease.
5. Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the previous 30 days.
6. Pregnancy or breastfeeding.
7. Current or previous participation in a psychological intervention.
8. Previous mindfulness experience, a documented psychiatric history, or consultation with a trauma psychologist during the current hospitalization.

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• Informed Consent Form (PDF, 2026-04-10)