Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients (NCT07566923) | Clinical Trial Compass
By InvitationNot Applicable
Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients
Turkey (Türkiye)60 participantsStarted 2026-05
Plain-language summary
This study will evaluate the effects of non-invasive vagus nerve stimulation in adolescents aged 12 to 18 years who have burn injuries. The study will include patients who have completed the acute phase after burn injury and who have symptoms such as anxiety, sleep problems, pain, or itching.
Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy together with non-invasive vagus nerve stimulation. The other group will receive only conventional physiotherapy. The treatment program will be applied 5 days per week for a total of 10 sessions.
The study will assess whether non-invasive vagus nerve stimulation improves anxiety, sleep quality, pain, itching, and autonomic nervous system function. These outcomes will be measured before and after the treatment program using clinical scales and heart rate variability measurements.
Who can participate
Age range
12 Years – 18 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:
* Being between 12 and 18 years of age
* Having completed the acute phase after burn injury, with at least 1 month and at most 1 year since the burn injury
* Having second- or third-degree burns involving 5% to 30% of total body surface area
* Having at least one of the following complaints: anxiety, poor sleep quality, pain, or itching
* Written informed consent provided by the parent or legal guardian, and willingness of the participant to take part in the study
* Ability to read and understand Turkish
Exclusion Criteria:
* Infection, ulcer, or scar tissue on the auricle
* Burn injury in the head and neck region that prevents application of the device to the auricular vagus nerve area
* Metallic implant in the skull, excessive sensitivity in the ear, ear injury, or ear inflammation
* Chronic pulmonary and/or cardiac disease
* Heart rate below 60 beats per minute
* Presence of a pacemaker, cochlear implant, or similar implanted device
* Uncontrolled hypertension
* Lack of cooperation
* Refusal or inability of the parent or legal guardian to sign the informed consent form
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
1
Change in anxiety level
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
2
Change in sleep-related symptoms
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
3
Change in pain intensity
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
4
Change in pruritus severity
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
5
Change in Root Mean Square of Successive Differences
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
6
Change in Standard Deviation of Normal-to-Normal Intervals
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks