VR headsets could replace pills for surgery anxiety

NCT ID NCT07463638

Symptom relief Sponsor: Tongji Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using virtual reality (VR) for mindfulness can help people feel less anxious and experience less pain during minor vascular surgery done under local anesthesia. 160 adults with varicose veins will be randomly assigned to either wear VR glasses with guided mindfulness exercises or receive standard care. The main goal is to see if VR reduces anxiety, with additional measures for pain, blood pressure, and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: virtual reality mindfulness intervention
What this could lead to: If it works, this could offer a safe, drug-free way to ease anxiety and pain during minor surgery.
What could go wrong: This is a small, early-stage trial. The VR intervention may not work better than standard care, and results may not apply to other types of surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Pain varicose disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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VR headsets could replace pills for surgery anxiety

What the study statuses mean