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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in anxiety level
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in sleep-related symptoms
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in pain intensity
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in pruritus severity
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Root Mean Square of Successive Differences
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Standard Deviation of Normal-to-Normal Intervals
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Low-Frequency/High-Frequency Ratio
Timeframe: Baseline and after completion of the 10-session treatment program, approximately 2 weeks