Mindfulness Intervention on Minimally Invasive Vascular Surgery

Tongji Hospital

Status: Not yet enrolling

Conditions: Anxiety; Pain

Treatments: Behavioral: Mindfulness intervention based on virtual reality technology

Study type: Interventional

Funder types: Other

Identifiers

NCT07463638

TJHL01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old.
2. ASA physical status classification I-III.
3. 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.
4. Scheduled for elective minimally invasive surgery for lower extremity varicose veins under local anesthesia.
5. Voluntary participation in this study with signed informed consent.
6. Able to cooperate with all examinations and follow-up visits required during the study.
7. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Mindfulness intervention based on virtual reality technology

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness intervention based on virtual reality technology

Routine Psychological Care

No Intervention group

Description:

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).