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Ear-Zap device may calm surgery nerves without pills

NCT ID NCT07495163

Symptom relief Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a non-invasive device that gently stimulates a nerve in the ear to reduce anxiety in people having major abdominal surgery. Over 282 participants will either get the real stimulation or a sham version for 60 minutes daily, starting two days before surgery. The goal is to see if this approach can lower anxiety and improve recovery without the side effects of standard anxiety medications.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation (taVNS) device
What this could lead to
If it works, this could offer a drug-free way to ease anxiety before and after major abdominal surgery, potentially improving recovery.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The effect may be small or no different from a placebo, and the device may not work for everyone.

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 282 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 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 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Between 18 and 85 years. 2. Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days. 3. ASA classification I-III. Exclusion Criteria: 1. Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear. 2. Pre-existing bradycardia (resting heart rate \< 50 beats/min) or third-degree atrioventricular block. 3. Presence of a cardiac pacemaker or other active electronic implants. 4. A documented history of traumatic brain injury within the past 6 months. 5. Chronic pain or long-term reliance on analgesic medications. 6. Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics. 7. Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales. 8. Women who were pregnant, lactating, or planning to conceive. 9. Current enrollment in other interventional clinical trials. 10. Anticipated direct transfer to the ICU immediately following surgery.

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As listed by the trial registrant

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

Major abdominal surgery Perioperative anxiety

How to take part

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

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Huzhou Central Hospital

    Huzhou, Zhejiang, China

  • Jiande First People's Hospital

    Meicheng, Zhejiang, China

  • The Second Affiliated Hospital of Jiaxing University

    Jiaxing, Zhejiang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

    Hangzhou, China

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