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ENROLLING BY INVITATION
NCT07566923
NA

Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients

Sponsor: Fenerbahce University

View on ClinicalTrials.gov

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

DEVICE

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.

OTHER

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)