Mindfulness Intervention on Minimally Invasive Vascular Surgery

Sponsor
Tongji Hospital
Study ID
NCT07463638
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Mindfulness intervention based on virtual reality technology — 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.

Study Details

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.

Key Dates

First listed
Mar 11, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness intervention based on virtual reality technology
    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.
  • No Intervention: Routine Psychological Care
    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).

Primary Outcome Measure

State-Trait Anxiety Inventory（STAI-State） [ Time Frame: Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure) ]

Central Contacts

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