Mindfulness Intervention on Minimally Invasive Vascular Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 interv

Первичные конечные точки

• State-Trait Anxiety Inventory（STAI-State） [Срок оценки: Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure)]

Вторичные конечные точки (6)

• Pain intensity [Срок оценки: Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure)]
• blood pressure [Срок оценки: 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 [Срок оценки: Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).]
• Sleep state [Срок оценки: Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).]
• Satisfaction scale [Срок оценки: 24 hours postoperatively (Day 1)]
• heart rate [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital — Ухань

Публикации

• Westerlinck P, Maes N, Coucke P. Assessing the Effect of a Mobile Application on Cancer Risk Health Literacy: A Cross-Sectional Study Design. Appl Clin Inform. 2025 Mar;16(2):447-462. doi: 10.1055/a-2516-1757. Epub 2025 Jan 15. PMID 39814048
• Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447. PMID 11408299
• Nowak A, Chmaj-Wierzchowska K, Kampioni M, Malinger A, Wilczak M. Evaluation of pain during diagnostic and surgical minihysteroscopy under local anesthesia. Arch Med Sci. 2023 Aug 17;21(2):463-470. doi: 10.5114/aoms/169979. eCollection 2025. PMID 40395882
• Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the low PMID 37652254
• Haridas Abhishek;Pawar Chandrashekara Rao Deepika;Ojha Moitri;Madhushree J.Assessment of pain and intraoperative anxiety by computerized and traditional local anesthetic methods in periodontal therapies: A comparative study[J].Journal of International Oral Health,2022.
• Rodriguez VH, Medrano CT, Plaza I. Wearable Sensors for Measuring Movement in Short Sessions of Mindfulness Sitting Meditation: A Pilot Study. J Healthc Eng. 2018 May 7;2018:7275049. doi: 10.1155/2018/7275049. eCollection 2018. PMID 29854363
• Slomski A. Mindfulness Noninferior to Medication for Quelling Anxiety. JAMA. 2023 Jan 3;329(1):12. doi: 10.1001/jama.2022.23506. No abstract available. PMID 36594959
• Marinovic DA, Hunter RL. Examining the interrelationships between mindfulness-based interventions, depression, inflammation, and cancer survival. CA Cancer J Clin. 2022 Sep;72(5):490-502. doi: 10.3322/caac.21733. Epub 2022 Jun 16. PMID 35709081

Идентификаторы

NCT: NCT07463638 · TJHL01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗