Mindfulness Intervention on Minimally Invasive Vascular Surgery

March 8, 2026 updated by: Wan Kuang, Tongji Hospital

Effect of Mindfulness Intervention Based on Virtual Reality Technology on Anxiety and Pain in Minimally Invasive Vascular Surgery Under Local Anesthesia: a Single-center, Prospective, Randomized Controlled Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study employed stratified block randomization, dividing subjects into three groups based on surgical type: ① Minimally invasive saphenous vein surgery group; ② Peripheral vascular intervention group; ③ Percutaneous coronary intervention (PCI) group. These three surgical categories exhibit significant differences in trauma level, surgical approach, and postoperative recovery period, which may independently influence anxiety outcomes. The stratified design controls for confounding effects of surgical procedure differences on study results (e.g., anxiety, pain). This study randomly assigned 160 patients whose groups had not yet been determined to two groups (intervention and control) in a 1:1 ratio. The block size was set to 4 based on the number of study groups. Randomization into 40 blocks was performed using SAS 9.4 software. Group allocation was concealed using the envelope method. A trained nurse sequentially opened envelopes according to patient enrollment order and assigned patients to the control or intervention group based on the allocation plan within each envelope.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Min Zhu, Graduate Student
  • Phone Number: 13545070566
  • Email: 824932159@qq.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18 years or older.
  2. ASA physical status classification of Grade I to Grade III.
  3. 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).
  4. 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.
  5. Voluntarily participates in this study and signs an informed consent form.
  6. Is able to cooperate with all examinations and follow-ups during the study process.
  7. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Mindfulness intervention based on virtual reality technology
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
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)
Visual Analogue Scale（ VAS）.The score from 0 to 10,where 0 means "no anxiety" and 10 means "the most serious 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
Time Frame: Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure)
The Numerical Rating Scale for Pain (NRS).The score from 0 to 10, where 0 means "no pain at all" and 10 means "the most severe pain"
Upon arrival at waiting room (baseline), 5 minutes after surgical incision (intraoperative), and immediately upon surgical closure (prior to operating room departure)
blood pressure
Time Frame: 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.
Includes systolic blood pressure (mmHg),diastolic blood pressure (mmHg).The higher the number, the higher the 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
Time Frame: Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).
Brief Fatigue Inventory（BFI）, with higher scores indicating greater fatigue.
Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).
Sleep state
Time Frame: Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).
Leeds Sleep Evaluation Questionnaire (LSEQ).The total score ranging from 0 to 100 points,the higher the score, the worse the sleep quality
Upon arrival at waiting room (baseline)and 24 hours postoperatively (Day 1).
Satisfaction scale
Time Frame: 24 hours postoperatively (Day 1)
Each dimension is scored using a 5-point Likert scale ranging from " never" (1 point) to "very frequently or always" (5 points).Higher scores indicate greater patient satisfaction
24 hours postoperatively (Day 1)
heart rate
Time Frame: 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.
Beat of the heart per minute.The bigger the number, the faster the heart rate.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJHL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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