NCT07463638

Mindfulness Intervention on Minimally Invasive Vascular Surgery

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Background: Patients undergoing minimally invasive vascular surgery under local anesthesia often experience significant anxiety and pain, which may compromise surgical outcomes. Virtual reality (VR)-based mindfulness interventions may offer a novel approach to enhance the perioperative experience. Methods: This single-center, prospective randomized controlled trial will enroll 160 patients, randomly assigned in a 1:1 ratio to either the intervention group (VR mindfulness intervention) or the control group (standard care). Primary outcome: State trait anxiety scale (STAI-State) measures anxiety. Secondary outcomes: Visual Analogue Scale (VAS) for anxiety, Numeric Rating Scale (NRS) for pain, vital signs, sleep quality, fatigue levels, satisfaction. Expected Results: VR mindfulness intervention is anticipated to significantly reduce anxiety and pain levels while improving sleep quality, fatigue levels, and patient satisfaction. Conclusion: As a safe, cost-effective, and immersive non-pharmacological intervention, VR mindfulness therapy holds promise for enhancing perioperative care quality.

Detailed description

This study employed stratified block randomization, dividing subjects into three groups based on surgical type: ① Minimally invasive saphenous vein surgery group; ② Peripheral vascular intervention group; ③ Percutaneous coronary intervention (PCI) group. These three surgical categories exhibit significant differences in trauma level, surgical approach, and postoperative recovery period, which may independently influence anxiety outcomes. The stratified design controls for confounding effects of surgical procedure differences on study results (e.g., anxiety, pain). This study randomly assigned 160 patients whose groups had not yet been determined to two groups (intervention and control) in a 1:1 ratio. The block size was set to 4 based on the number of study groups. Randomization into 40 blocks was performed using SAS 9.4 software. Group allocation was concealed using the envelope method. A trained nurse sequentially opened envelopes according to patient enrollment order and assigned patients to the control or intervention group based on the allocation plan within each envelope.

Conditions

• Anxiety
• Pain

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness intervention based on virtual reality technology	On the day of surgery, the operating room staff brought patients to the preoperative waiting area in advance. Patients in the intervention group were assigned to a dedicated room within the preoperative waiting area. They were invited to sit in comfortable chairs and observe their surroundings. Operating room nurses trained in mindfulness assisted patients in putting on Huawei VR Glasses. They selected the pre-recorded Mindfulness Theory Course 1 + Guided Mindfulness Audio A for the first intervention. Subsequently, a second intervention was conducted when patients entered the operating room and surgery commenced. Operating room nurses assisted patients in wearing the Huawei VR Glass and selected the pre-recorded mindfulness theory course 2 + mindfulness guidance audio B.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: China