Mindfulness Intervention on Minimally Invasive Vascular Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

VR-Based Mindfulness Intervention: 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.

Study summary

The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction.

The main questions this study aims to answer are:

* Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care?
* Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups.

Participants in the VR-based mindfulness group will:

* Receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area.
* Begin a VR-based mindfulness session at the start of surgery. Each intraoperative session lasts 25 minutes and may be repeated until the end of surgery.

Participants in the control group will receive routine psychological care before and during surgery.

Participants in both groups will:

* Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and after surgery. The 25-minute assessment corresponds to the completion of the first 25-minute intraoperative VR-based mindfulness session in the intervention group.
* Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery.
* Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery.
* Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day.
* Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day.
* Complete a satisfaction assessment on the first postoperative day.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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