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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory（STAI-State）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-
- •Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.
- •Voluntary participation in this study with signed informed consent.
- •Able to cooperate with all examinations and follow-up visits required during the study.
- •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.
排除标准
- •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.
- •Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days.
- •Pregnancy or breastfeeding.
- •Currently receiving or previously participated in psychological intervention.
- •Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.
研究组 & 干预措施
Mindfulness intervention based on virtual reality technology
On the day of surgery, the first intervention took place in the preoperative waiting area. A mindfulness-trained operating room nurse guided the patient in wearing Huawei VR glasses and selecting pre-recorded mindfulness audio track A. The second intervention occurred in the operating room at the start of surgery. The patient again wore Huawei VR glasses and selected pre-recorded mindfulness audio track B.
干预措施: Mindfulness intervention based on virtual reality technology (Behavioral)
Routine Psychological Care
The control group patients received routine psychological care under identical medical conditions, including preoperative visits (providing information about the surgical procedure, expected outcomes, and other surgery-related details) and psychological support (comfort and encouragement).
结局指标
主要结局
State-Trait Anxiety Inventory（STAI-State）
时间窗: Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure)
Total scores ranging from 20 to 80, where higher scores indicate greater anxiety.
次要结局
- Anxiety(Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure))
- Pain intensity(Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure))
- blood pressure(Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative),monitor every 5 minutes starting from the beginning of surgery until the end of surgery.)
- fatigued state(Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).)
- Sleep state(Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).)
- Satisfaction scale(24 hours postoperatively (Day 1))
- heart rate(Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative),monitor every 5 minutes starting from the beginning of surgery until the end of surgery.)