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Ear-Zapping device may soothe burn Victims' anxiety and pain

NCT ID NCT07566871

Symptom relief Sponsor: Fenerbahce 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study tests a non-invasive device that gently stimulates a nerve in the ear to see if it can reduce anxiety, improve sleep, and lessen pain and itching in adults recovering from burn injuries. About 60 participants will either get standard physical therapy plus this nerve stimulation or standard therapy alone for 10 sessions over two weeks. Researchers will measure changes in anxiety, sleep quality, pain, itching, and heart rate before and after treatment to see if the stimulation adds extra benefit.

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 60 people

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

Started

May 2026

Expected to finish

Sep 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

18 to 65 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: * Adults aged 18 to 65 years * Patients who have completed the acute phase of burn injury * Burn injury occurred at least 1 month and no more than 1 year before enrollment * Second- or third-degree burn involving 5% to 30% of total body surface area * Presence of at least one complaint related to anxiety, sleep quality, pain, or itching * Able to read and understand Turkish * Willing to participate in the study * Written informed consent provided Exclusion Criteria: * Infection, ulcer, or scar tissue on the auricle * Burn injury in the head and neck region preventing application of the device over the auricular branch of the vagus nerve * Metallic implant in the skull * Excessive sensitivity, injury, or inflammation in the ear * Chronic pulmonary disease and/or chronic cardiac disease * Resting heart rate below 60 beats per minute * Presence of a pacemaker, cochlear implant, or similar implanted device * Uncontrolled hypertension * Lack of cooperation or inability to comply with study procedures

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Conditions

The condition(s) this trial relates to.

anxiety disorder burn insomnia Pain Pruritus

As listed by the trial registrant

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

Burn injury

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Kartal Dr. Lütfi Kırdar City Hospital Burn Unit

    Istanbul, Kartal, 34865, Turkey (Türkiye)

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