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

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.

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.

Inclusion Criteria:

1. Age ≥18 years old.
2. ASA physical status classification I-III.
3. 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.
4. Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.
5. Voluntary participation in this study with signed informed consent.
6. Able to cooperate with all examinations and follow-up visits required during the study.
7. No other severe systemic diseases or surgical contraindications (e.g., severe cardiopulmonary dysfunction, coagulation abnormalities) that may compromise surgical safety or interpretation of study results.

Exclusion Criteria:

1. Cognitive impairment (Mini-Mental State Examination [MMSE] score ≤26).
2. Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness).
3. History of the same type of surgery.
4. Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis.
5. Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days.
6. Pregnancy or breastfeeding.
7. Currently receiving or previously participated in psychological intervention.
8. Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.