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Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients
Sponsor: Fenerbahce University
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.
Official title: The Effects of Non-Invasive Vagus Nerve Stimulation on Anxiety, Sleep Quality, Pain, Itching, and Autonomic Functions in Burn Patients Aged 12-18
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-05-11
Completion Date
2026-09
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Non-Invasive Vagus Nerve Stimulation
Non-invasive vagus nerve stimulation will be applied using electrodes placed on the tragus and concha regions of both ears. Stimulation will be delivered with a biphasic asymmetrical waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz for 20 minutes. The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached. The intervention will be applied 5 days per week for a total of 10 sessions.
Conventional Physiotherapy
Participants will receive an individualized conventional physiotherapy program based on their clinical needs. The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management. Each session will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
Locations (1)
Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
Istanbul, Kartal, Turkey (Türkiye)