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Ear zap may soothe kids after surgery

NCT ID NCT07394647

Symptom relief Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive device that delivers mild electrical pulses to the ear (taVNS) can prevent confusion and restlessness when children wake up from anesthesia after tonsillectomy. 120 children aged 3-8 will be randomly assigned to receive either real taVNS or a sham device during and after surgery. Researchers will observe how calmly they wake and any side effects, aiming to find a safe, drug-free way to improve recovery.

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 help children wake up more calmly after surgery, reducing distress for kids and families.
What could go wrong
This is a small, early-stage trial with only 120 children. The sham group may also show benefits, and the effect may not be strong enough to change standard care.

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 120 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

3 to 8 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: * Children aged 3 to 8 years. * Patients receiving care at The First Affiliated Hospital of Zhejiang Chinese Medical University with a diagnosis of tonsil and/or adenoid hypertrophy, scheduled for tonsillectomy and/or adenoidectomy under sevoflurane inhalation general anesthesia. * American Society of Anesthesiologists (ASA) physical status I-II. * Ability to understand the study procedures and assessment scales, and to communicate effectively with study personnel. Exclusion Criteria: * ASA physical status III-IV, or presence of hepatic or renal dysfunction, cardiovascular disease, or endocrine disorders. * Neuromuscular disorders or dermatitis of the left auricle. * Recent respiratory infection, developmental delay, or autism spectrum disorder. * Receipt of specialized care, residence in social welfare institutions, or any other condition that may interfere with study participation. * Current enrollment in another clinical trial.

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium

As listed by the trial registrant

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

Emergence agitation Emergence delirium

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

    Hangzhou, Zhejiang, 310006, China

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