About this trial
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: 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.
Eligibility criteria
Qualifiers
Age ≥18 years old.
ASA physical status classification I-III.
Diagnosis of superficial varicose veins confirmed by clinical examination and imaging studies (e.g., Doppler ultrasound, digital subtraction angiography), with documented venous insufficiency and great saphenous vein varicosity; CEAP classification grade 3-5.
Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.
Disqualifiers
Cognitive impairment (Mini-Mental State Examination [MMSE] score ≤26).
Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness).
History of the same type of surgery.
Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis.
Trial design
Treatments tested in this trial
- Mindfulness intervention based on virtual reality technology