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Enrolling By Invitation
NCT07566923
Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients
Conditions: Burn Injury
Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Fenerbahce University
Location: Kartal Dr. Lütfi Kırdar City Hospital Burn Unit Istanbul Kartal
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07566923). StuddyBuddy aggregates publicly available trial information.