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Mindfulness Intervention on Minimally Invasive Vascular Surgery
Sponsor: Tongji Hospital
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 a VR-based mindfulness session in the preoperative waiting area. * Begin a VR-based mindfulness session at the start of surgery. The intraoperative intervention will be repeated till 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, following the first completion of intraoperative VR-based mindfulness session, and after surgery. The third assessment will be conducted at the corresponding intraoperative time point in the control 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.
Official title: Effect of Mindfulness Intervention Based on Virtual Reality Technology on Anxiety and Pain in Minimally Invasive Vascular Surgery Under Local Anesthesia: a Single-center, Prospective, Randomized Controlled Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-11
Completion Date
2027-07
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
VR-Based Mindfulness Intervention
The VR-based mindfulness intervention will be delivered in two stages on the day of surgery. Before surgery, participants in the intervention group will be transferred to a separate room within the preoperative waiting area, where a mindfulness-trained nurse will assist them in using Huawei VR Glass to receive prerecorded mindfulness education and guided mindfulness practice. At the start of surgery, participants will receive an intraoperative VR-based mindfulness intervention using prerecorded guided mindfulness content, assisted by a trained nurse. Following the completion of the first intraoperative VR-based mindfulness session and the corresponding anxiety assessment, the intervention will be resumed and may be repeated according to the duration of surgery until the end of surgery.
Locations (1)
Tongji Hospital
Wuhan, Hubei, China