Mindfulness Intervention on Minimally Invasive Vascular Surgery

NCT07463638 | Not Yet Recruiting

• 1 other identifier: TJHL01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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: Visual Analogue Scale (VAS) for anxiety, 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.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory（STAI-State）

  Total scores ranging from 20 to 80, where higher scores indicate greater anxiety.

  Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure)

Secondary Outcomes (7)

• Anxiety

  Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative), and immediately upon surgical closure (prior to operating room departure)

• Pain intensity

  Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure)

• blood pressure

  Upon arrival at waiting room (baseline), immediately prior to departure from waiting room (preoperative),monitor every 5 minutes starting from the beginning of surgery until the end of surgery.

• fatigued state

  Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).

• Sleep state

  Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).

Study Arms (2)

Mindfulness intervention based on virtual reality technology

EXPERIMENTAL

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.

Behavioral: Mindfulness intervention based on virtual reality technology

Routine Psychological Care

NO INTERVENTION

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).

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.

Mindfulness intervention based on virtual reality technology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• ASA physical status classification of Grade I to Grade III.
• Diagnosis of one of the following vascular diseases confirmed by clinical examination and imaging studies (e.g., Doppler ultrasound, venography, DSA, CTA, MRA, CTPA, etc.): ① Arterial disease: Stenosis or occlusion of coronary arteries, iliac arteries, renal arteries, superior (or inferior) mesenteric arteries, etc., with ≥70% narrowing.② Peripheral venous disease: Grade C3-C5 lower extremity varicose veins, deep vein thrombosis (DVT), chronic venous insufficiency (CVI).
• Meets one of the following indications for minimally invasive vascular surgery under local anesthesia: ① Minimally invasive surgery for lower extremity varicose veins; ② Percutaneous (arterial or venous) stent placement; ③ Percutaneous (arterial or venous) balloon angioplasty; ④ Percutaneous inferior vena cava filter placement.
• Voluntarily participates in this study and signs an informed consent form.
• Is able to cooperate with all examinations and follow-ups during the study process.
• Has no other severe systemic diseases or surgical contraindications, such as severe cardiopulmonary dysfunction or coagulation disorders, that may affect surgical safety or the interpretation of study results.

You may not qualify if:

• Cognitive impairment (Mini-Mental State Examination score ≤26).
• Inability to wear VR equipment, or presence of sensory impairment (blindness, deafness).
• History of similar surgical procedures.
• Chronic or acute pain unrelated to the diagnosis of peripheral vascular disease.
• Oral opioid or nonsteroidal anti-inflammatory drug use within the past 30 days.
• Pregnancy or lactation.
• Current or past participation in psychological interventions.
• Prior mindfulness experience, documented psychiatric history, or consultation with a trauma psychologist during the current hospitalization.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

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MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Min Zhu, Graduate Student

CONTACT

13545070566; 824932159@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: supervisor nurse

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)