Mindfulness Intervention on Minimally Invasive Vascular Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
The goal of this clinical trial is to learn whether a virtual reality (VR)-based mindfulness intervention can reduce anxiety and pain in adults undergoing minimally invasive surgery for lower-extremity varicose veins under local anesthesia. The study will also examine whether the intervention affects vital signs, fatigue, sleep quality, and patient satisfaction.
The main questions this study aims to answer are:
* Does VR-based mindfulness reduce patients' anxiety during surgery compared with routine psychological care? * Does VR-based mindfulness reduce perioperative pain and improve other patient-reported and physiological outcomes? Researchers will compare a VR-based mindfulness intervention with routine psychological care. A total of 160 participants will be randomly assigned to one of the two groups.
Participants in the VR-based mindfulness group will:
* Receive an approximately 15-minute VR-based mindfulness session in the preoperative waiting area. * Begin a VR-based mindfulness session at the start of surgery. Each intraoperative session lasts 25 minutes and may be repeated until the end of surgery.
Participants in the control group will receive routine psychological care before and during surgery.
Participants in both groups will:
* Complete assessments of state anxiety approximately 30 minutes before surgery, immediately before surgery, 25 minutes after the start of surgery, and after surgery. The 25-minute assessment corresponds to the completion of the first 25-minute intraoperative VR-based mindfulness session in the intervention group. * Rate their pain before surgery and, at the end of surgery, report both their current pain intensity and the highest level of pain experienced during surgery. * Have blood pressure and heart rate measured before surgery and monitored at regular intervals throughout surgery. * Complete assessments of fatigue in the preoperative waiting area and again on the first postoperative day. * Complete assessments of sleep quality in the preoperative waiting area and again on the first postoperative day. * Complete a satisfaction assessment on the first postoperative day.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
American Society of Anesthesiologists (ASA) physical status I-III.
Clinically and imaging-confirmed superficial lower-extremity varicose veins with venous insufficiency and great saphenous vein involvement, with CEAP class C3-C5.
Scheduled for elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia.
Disqualifiers
Cognitive impairment according to the prespecified study screening criterion (MMSE score ≤26).
Unable to wear or use the VR device, including because of blindness or deafness.
Previous history of the same type of varicose vein surgery.
Acute or chronic pain unrelated to peripheral vascular disease.
Trial design
Design model
Parallel
Treatments tested in this trial
VR-Based Mindfulness Intervention
BehavioralThe VR-based mindfulness intervention will be delivered in two perioperative stages on the day of surgery. Approximately 30 minutes before surgery, participants assigned to the intervention group will be transferred to a dedicated room in the preoperative waiting area. A mindfulness-trained waiting-area nurse will assist participants in wearing Huawei VR Glass and receiving a prerecorded mindfulness theory course together with guided mindfulness Audio A for approximately 15 minutes. At the start of surgery, another mindfulness-trained research nurse will assist participants in wearing Huawei VR Glass and receiving prerecorded guided mindfulness Audio B. Each intraoperative session will last 25 minutes and will be repeated until the end of surgery.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: VR-Based Mindfulness InterventionExperimental treatment 1 intervention
Group B: Routine Psychological CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
State-Trait Anxiety Inventory-State Subscale (STAI-State)
The STAI-State is a 20-item self-report measure of state anxiety. Each item is rated on a 4-point scale, yielding a total score ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.
Time frame
Approximately 30 min before surgery, immediately before surgery, 25 min after surgery starts, and at surgery end. The 25-min assessment follows the first VR mindfulness session in the intervention group; controls are assessed at the same timeSecondary outcomes
1
Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. At the end of surgery, participants will report both their highest pain experienced during surgery and their current pain intensity.
Time frame
Approximately 30 min before surgery and at surgery end, when maximum intraoperative pain and current pain intensity will be assessed.2
blood pressure
Systolic and diastolic blood pressure will be measured in mmHg using the perioperative patient monitor.
Time frame
Approximately 30 min before surgery, immediately before surgery, and every 5 min from the start of surgery until the end of surgery.3
Fatigue (Brief Fatigue Inventory, BFI)
Fatigue will be assessed using the 9-item Brief Fatigue Inventory (BFI). Each item is scored from 0 to 10, with higher scores indicating greater fatigue.
Time frame
Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1, assessing fatigue related to the day of surgery.4
Sleep Quality (Leeds Sleep Evaluation Questionnaire, LSEQ)
Sleep quality will be assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), which includes 10 items across four domains: getting to sleep, sleep quality, awakening, and post-awakening state. Each item is rated on a 100-mm visual analogue scale.
Time frame
Upon arrival in the preoperative waiting area (baseline) and on postoperative day 1.Sponsors and contacts
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Source ClinicalTrials.gov
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