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NCT Number: NCT07463638

Mindfulness Intervention on Minimally Invasive Vascular Surgery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old.
  • ASA physical status classification I-III.
  • Diagnosis of superficial varicose veins confirmed by clinical examination and imaging studies (e.g., Doppler ultrasound, digital subtraction angiography), with documented venous insufficiency and great saphenous vein varicosity; CEAP classification grade 3-5.
  • Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.
  • Voluntary participation in this study with signed informed consent.
  • Able to cooperate with all examinations and follow-up visits required during the study.
  • No other severe systemic diseases or surgical contraindications (e.g., severe cardiopulmonary dysfunction, coagulation abnormalities) that may compromise surgical safety or interpretation of study results.

Exclusion criteria

  • Cognitive impairment (Mini-Mental State Examination [MMSE] score ≤26).
  • Inability to wear VR equipment, or presence of sensory impairment (blindness or deafness).
  • History of the same type of surgery.
  • Presence of chronic or acute pain unrelated to peripheral vascular disease diagnosis.
  • Oral opioid or nonsteroidal anti-inflammatory drug (NSAID) use within the past 30 days.
  • Pregnancy or breastfeeding.
  • Currently receiving or previously participated in psychological intervention.
  • Prior mindfulness experience, documented history of psychiatric illness in medical records, or consultation with a trauma psychologist during the current hospitalization.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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"

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zhu, Graduate Student

CONTACT

[email protected]

13545070566

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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