An interventional study of Non-Invasive Vagus Nerve Stimulation and Conventional Physiotherapy in Burn Injury, sponsored by Fenerbahce University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Treatment
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.
Burn injuries may cause long-term physical and psychological symptoms in pediatric and adolescent patients, including pain, itching, sleep problems, anxiety, and changes in autonomic nervous system activity. These symptoms may negatively affect recovery and rehabilitation outcomes.
Non-invasive vagus nerve stimulation is a transcutaneous neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This stimulation may influence autonomic nervous system regulation and may have potential effects on pain, sleep, anxiety, itching, and physiological recovery.
This study is designed as a randomized interventional study. Adolescents aged 12 to 18 years with burn injuries will be randomly assigned to an intervention group or a control group. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only.
The non-invasive vagus nerve stimulation will be applied through 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. Each stimulation session will last 20 minutes. The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached. If the participant feels unwell during the stimulation, the procedure will be stopped.
Both groups will receive individualized conventional physiotherapy programs based on their clinical needs. These programs may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management. Conventional physiotherapy sessions will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
Outcome assessments will be performed before the start of treatment and after completion of the 10-session treatment program. Anxiety will be assessed using the Beck Anxiety Inventory. Sleep-related symptoms will be assessed using the Adolescent Insomnia Scale. Pain will be assessed using the Visual Analog Scale. Itching severity will be assessed using the 12-Item Pruritus Severity Scale. Autonomic nervous system function will be evaluated using heart rate variability measurements recorded with a Polar H10 heart rate sensor and analyzed with Kubios HRV software.
The aim of the study is to determine whether non-invasive vagus nerve stimulation, when added to conventional physiotherapy, improves anxiety, sleep quality, pain, itching, and autonomic function in adolescents with burn injuries.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Fenerbahce University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy. The treatment will be applied 5 days per week for a total of 10 sessions.
Device: Non-Invasive Vagus Nerve Stimulation · Other: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only. The treatment will be applied 5 days per week for a total of 10 sessions.
Other: Conventional Physiotherapy
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.
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.
Change in anxiety level
Anxiety level will be assessed using the Beck Anxiety Inventory. The scale consists of 21 items scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate higher anxiety severity.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in sleep-related symptoms
Sleep-related symptoms will be assessed using the Adolescent Insomnia Scale. The scale includes 13 items and evaluates sleep onset, sleep maintenance, and sleep dissatisfaction/disturbances. Total scores range from 0 to 52, with higher scores indicating more severe insomnia symptoms.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in pain intensity
Pain intensity will be assessed using the Visual Analog Scale. Participants will mark their pain level on a 100-mm line, where higher scores indicate greater pain intensity.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in pruritus severity
Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale. The scale evaluates the severity, frequency, duration, distribution, and impact of itching on daily life and sleep. Higher scores indicate more severe pruritus.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Root Mean Square of Successive Differences
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.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Standard Deviation of Normal-to-Normal Intervals
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.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Change in Low-Frequency/High-Frequency Ratio
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.
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Plan to share: No — Individual participant data will not be shared due to the involvement of pediatric participants and the sensitive nature of clinical and health-related data. Study results may be reported in aggregate form in scientific presentations or publications, without identifying individual participants.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2026, 4 months after the start.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 4 months is below that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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Fenerbahce University