Mindfulness Intervention on Minimally Invasive Vascular Surgery

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Jan 2027 → Jun 2027
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Primary endpoint(s) modified Show 8 more changesShow less
    • Start date: Jul 2026 to Oct 2026
    • Primary completion pushed from Jan 2027 to Jun 2027
    • Study completion pushed from Jan 2027 to Jul 2027
    • Interventions modified
    • Secondary endpoints revised (6)
    • Study description expanded, about 193 words
    • Publications: details revised at 17 of 22 entries
    • Eligibility criteria shortened, about 2 words
  2. Notable Start date: Mar 2026 to Jul 2026v2 Show 4 more changesShow less
    • Primary and study completion pushed from Oct 2026 to Jan 2027
    • Eligibility criteria shortened, about 63 words
    • Secondary endpoints: 7 to 6
    • Study description shortened, about 72 words
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
201 trials monitored
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3,284 trials monitored
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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.
Trial Details
NCT Number NCT07463638
Lead Sponsor Tongji Hospital
Conditions
(from sponsor)
Anxiety, Pain, Varicose Veins of Lower Limb
Related terms Anxiety Disorders, Pain
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov