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NCT07463638
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Conditions: Anxiety, Pain, Varicose Veins of Lower Limb
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Tongji Hospital
Location: Tongji Hospital Wuhan Hubei
Summary
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 a VR-based mindfulness session in the preoperative waiting area.
* Begin a VR-based mindfulness session at the start of surgery. The intraoperative intervention will be repeated till 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, following the first completion of intraoperative VR-based mindfulness session, and after surgery. The third assessment will be conducted at the corresponding intraoperative time point in the control 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
Inclusion Criteria
1. Adults aged 18 years or older.
2. American Society of Anesthesiologists (ASA) physical status I-III.
3. Clinically and ultrasonographically confirmed lower-extremity varicose veins, classified as CEAP C3-C5.
4. Scheduled for elective minimally invasive surgery for lower-extremity varicose veins under local anesthesia.
5. Able to provide written informed consent and complete study-related assessments.
6. Clinically suitable for the planned surgical procedure and study-related interventions.
Exclusion Criteria
1. Cognitive, sensory, or communication impairments that prevent participation in the intervention or completion of study-related assessments.
2. Medical conditions or contraindications that may compromise participant safety or substantially interfere with study outcomes.
3. Significant pain conditions unrelated to the target vascular disease that may interfere with pain assessment.
4. Regular use of analgesic or sedative medications that may substantially affect study outcomes.
5. Pregnancy or breastfeeding.
6. Current or recent participation in structured psychological or mindfulness interventions that may influence anxiety assessment.
7. Psychiatric conditions that may substantially interfere with study participation or outcome assessment.
Source: ClinicalTrials.gov (NCT07463638). StuddyBuddy aggregates publicly available trial information.