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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Mindfulness intervention based on virtual reality technology
BehavioralOn 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.
Treatment groups
Trial outcomes
Primary outcomes
State-Trait Anxiety Inventory（STAI-State）
Total scores ranging from 20 to 80, where higher scores indicate greater anxiety.
Secondary outcomes
Pain intensity
The Numerical Rating Scale for Pain (NRS).The score from 0 to 10, where 0 means "no pain at all" and 10 means "the most severe pain"
blood pressure
Includes systolic blood pressure (mmHg),diastolic blood pressure (mmHg).The higher the number, the higher the blood pressure.
fatigued state
Brief Fatigue Inventory（BFI）, with higher scores indicating greater fatigue.
Sleep state
Leeds Sleep Evaluation Questionnaire (LSEQ).The total score ranging from 0 to 100 points,the higher the score, the worse the sleep quality
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: