[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628592":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":43,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":18,"overallStatus":68,"whyStopped":18,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mindfulness intervention based on virtual reality technology","EXPERIMENTAL","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.",[13],"Behavioral: Mindfulness intervention based on virtual reality technology",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Psychological Care","NO_INTERVENTION","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).",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","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.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Min Zhu, Graduate Student","CONTACT","13545070566","824932159@qq.com",[31],{"facility":5,"status":18,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":18},"Wuhan","Hubei","430000","China","CN",{"type":38,"coordinates":39},"Point",[40,41],114.26667,30.58333,{"lat":41,"lon":40},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Wan Kuang","supervisor nurse","100628592","mindfulness-intervention-on-minimally-invasive-vascular-surgery-100628592",false,"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","Inclusion Criteria:\n\n1. Age ≥18 years old.\n2. ASA physical status classification I-III.\n3. 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.\n4. Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.\n5. Voluntary participation in this study with signed informed consent.\n6. Able to cooperate with all examinations and follow-up visits required during the study.\n7. 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.\n\nExclusion Criteria:\n\n1. Cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score ≤26).\n2. Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness).\n3. History of the same type of surgery.\n4. Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis.\n5. Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days.\n6. Pregnancy or breastfeeding.\n7. Currently receiving or previously participated in psychological intervention.\n8. Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.",true,"ALL","18 Years","80 Years",{"count":59,"type":60},160,"ESTIMATED","INTERVENTIONAL",[63],"NA","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.",[66,67],"Anxiety","Pain","NOT_YET_RECRUITING","2026-06-15",{"date":71,"type":72},"2026-06-17","ACTUAL",{"date":74,"type":60},"2026-07",{"date":76,"type":60},"2027-01",{"name":5,"class":6},1]