Non-Invasive Vagus Nerve Stimulation: Non-invasive vagus nerve stimulation will be applied using a Vagustim device. Electrodes will be placed on the tragus and the anterior and posterior surfaces of the concha of both ears. Stimulation will be applied continuously for 20 minutes per session with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. Stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. The procedure will be stopped if the participant feels unwell.
Conventional Physiotherapy: Conventional physiotherapy will be planned according to each participant's needs and will be provided by a physiotherapist. The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema. Sessions will be performed 5 days per week for a total of 10 sessions, with each session lasting approximately 45 minutes.
Study summary
This study will evaluate the effects of non-invasive vagus nerve stimulation (nVNS) in adults with burn injuries. Burn patients may experience anxiety, poor sleep quality, pain, itching, and changes in autonomic nervous system function during recovery.
Participants will be randomly assigned to one of two groups. The intervention group will receive conventional physiotherapy plus nVNS, and the control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. nVNS will be applied through electrodes placed on the external ear for 20 minutes per session.
Anxiety, sleep quality, pain, itching, and autonomic function will be assessed before and after the treatment period. Autonomic function will be evaluated using heart rate variability measurements. The results will help determine whether nVNS may be a useful supportive method in the rehabilitation of burn patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Adults aged 18 to 65 years
* Patients who have completed the acute phase of burn injury
* Burn injury occurred at least 1 month and no more than 1 year before enrollment
* Second- or third-degree burn involving 5% to 30% of total body surface area
* Presence of at least one complaint related to anxiety, sleep quality, pain, or itching
* Able to read and understand Turkish
* Willing to participate in the study
* Written informed consent provided
Exclusion Criteria:
* Infection, ulcer, or scar tissue on the auricle
* Burn injury in the head and neck region preventing application of the device over the auricular branch of the vagus nerve
* Metallic implant in the skull
* Excessive sensitivity, injury, or inflammation in the ear
* Chronic pulmonary disease and/or chronic cardiac disease
* Resting heart rate below 60 beats per minute
* Presence of a pacemaker, cochlear implant, or similar implanted device
* Uncontrolled hypertension
* Lack of cooperation or inability to comply with study procedures
Primary outcome measure(s)
Change in Anxiety Level — Baseline and after completion of 10 treatment sessions, up to 2 weeks Anxiety level will be assessed using the Beck Anxiety Inventory. The scale includes 21 items scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate greater anxiety severity.
Change in Sleep Quality — Baseline and after completion of 10 treatment sessions, up to 2 weeks Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The scale evaluates sleep quality and sleep disturbances over the previous month. The total score ranges from 0 to 21, and higher scores indicate poorer sleep quality.
Change in Pain Intensity — Baseline and after completion of 10 treatment sessions, up to 2 weeks Pain intensity will be assessed using a visual analog scale. Participants will mark their pain level on a 100-mm line, where higher scores indicate greater pain intensity.
Change in Pruritus Severity — Baseline and after completion of 10 treatment sessions, up to 2 weeks Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale. The scale evaluates multiple aspects of itching, including location, duration, frequency, intensity, scratching behavior, emotional effects, sleep disturbance, daily activity effects, and quality-of-life impact. Higher scores indicate more severe itching.
Change in Root Mean Square of Successive Differences — Baseline and after completion of 10 treatment sessions, up to 2 weeks Autonomic nervous system function will be assessed using the root mean square of successive differences between normal RR intervals derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The root mean square of successive differences will be reported in milliseconds.
Change in Standard Deviation of Normal-to-Normal Intervals — Baseline and after completion of 10 treatment sessions, up to 2 weeks Autonomic nervous system function will be assessed using the standard deviation of normal-to-normal intervals derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The standard deviation of normal-to-normal intervals will be reported in milliseconds.
Change in Low-Frequency/High-Frequency Ratio — Baseline and after completion of 10 treatment sessions, up to 2 weeks Autonomic nervous system function will be assessed using the low-frequency/high-frequency ratio derived from heart rate variability analysis. RR interval data will be recorded with a Polar H10 heart rate sensor during a 5-minute resting measurement and analyzed using Kubios HRV software. The low-frequency/high-frequency ratio will be reported as a ratio.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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