By InvitationNot Applicable

Non-Invasive Vagus Nerve Stimulation in Patients With Acute Burn Injuries

Turkey (Türkiye)50 participantsStarted 2026-05

Plain-language summary

This randomized controlled study will investigate the effects of non-invasive vagus nerve stimulation on inflammatory response and functional recovery in adults with acute burn injuries. Participants will be adults aged 18 to 65 years with second- or third-degree burns involving 5% to 30% of total body surface area and who are enrolled within the first 72 hours after hospitalization. Participants will be randomly assigned to one of two groups. The intervention group will receive non-invasive auricular vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only. The stimulation will be applied through surface electrodes placed on the auricular region of the ear for 20 minutes per session, for a total of 10 sessions. The main outcomes will be inflammatory response, assessed by C-reactive protein levels, and functional recovery, assessed by the Functional Independence Measure. Assessments will be performed before the intervention and after completion of the 10 treatment sessions.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 65 years * Diagnosed with second- or third-degree burn injury involving 5% to 30% of total body surface area * Enrolled within the first 72 hours after hospitalization due to burn injury * Stable vital signs and general clinical condition suitable for the intervention * Able to read and understand Turkish and communicate adequately * Provided written informed consent Exclusion Criteria: * Severe burn injury in the head and neck region preventing application of the device to the auricular vagus nerve area * Chronic pulmonary and/or cardiac disease * Heart rate below 60 beats per minute * History of epilepsy, severe psychiatric disease, or neurological disorder * Presence of a cardiac pacemaker or implantable electronic device * Autoimmune or chronic systemic inflammatory disease * Cognitive impairment preventing adherence to the study protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in C-Reactive Protein Level

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Functional Independence Measure Score

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Joint Range of Motion

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Muscle Strength

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Trial details

NCT IDNCT07574580

SponsorFenerbahce University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Acute Burns trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in C-Reactive Protein Level

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Functional Independence Measure Score

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Joint Range of Motion

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session

Change in Muscle Strength

Timeframe: Baseline and Week 4, immediately after completion of the 10th treatment session