Burn InjuryNCT07566923
Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients
A study testing Non-Invasive Vagus Nerve Stimulation and Conventional Physiotherapy in people with Burn Injury, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Non-Invasive Vagus Nerve Stimulation and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between 12 and 18 years of age
- Having completed the acute phase after burn injury, with at least 1 month and at most 1 year since the burn injury
- Having second- or third-degree burns involving 5% to 30% of total body surface area
- Having at least one of the following complaints: anxiety, poor sleep quality, pain, or itching
- Written informed consent provided by the parent or legal guardian, and willingness of the participant to take part in the study
- Ability to read and understand Turkish
Who cannot join
- Infection, ulcer, or scar tissue on the auricle
- Burn injury in the head and neck region that prevents application of the device to the auricular vagus nerve area
- Metallic implant in the skull, excessive sensitivity in the ear, ear injury, or ear inflammation
- Chronic pulmonary and/or cardiac disease
- Heart rate below 60 beats per minute
- Presence of a pacemaker, cochlear implant, or similar implanted device
Show all 9Show fewer
- Uncontrolled hypertension
- Lack of cooperation
- Refusal or inability of the parent or legal guardian to sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
Istanbul, Kartal, 34865
About this study
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
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.
Read the detailed description
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.
- Conditions
- Burn Injury
- Being tested
- Non-Invasive Vagus Nerve Stimulation, Conventional Physiotherapy
- Keywords
- Non-invasive vagus nerve stimulation, Burn injury, Adolescent burn patients, Anxiety, Sleep quality, Pain, Pruritus
- Medical subject headings
- Burns, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Pain, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Vagus Nerve StimulationDevice
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy | Experimental | 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. Receives: Device: Non-Invasive Vagus Nerve Stimulation; Other: Conventional Physiotherapy |
| Conventional Physiotherapy | Active comparator | Participants in this group will receive conventional physiotherapy only. The treatment will be applied 5 days per week for a total of 10 sessions. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start11 May 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed before and after the 10-session treatment program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Asst. Prof., Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566923
- Sponsor's protocol ID
- KartalYanık
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07566923
- Acronym / sponsor ID
- KartalYanık
- Conditions
- Burn Injury
- Keywords
- Non-invasive vagus nerve stimulation, Burn injury, Adolescent burn patients, Anxiety, Sleep quality, Pain, Pruritus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed before and after the 10-session treatment program.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy | Experimental | Device: Non-Invasive Vagus Nerve Stimulation, Other: Conventional PhysiotherapyParticipants 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. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants in this group will receive conventional physiotherapy only. The treatment will be applied 5 days per week for a total of 10 sessions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Being between 12 and 18 years of age
- Having completed the acute phase after burn injury, with at least 1 month and at most 1 year since the burn injury
- Having second- or third-degree burns involving 5% to 30% of total body surface area
- Having at least one of the following complaints: anxiety, poor sleep quality, pain, or itching
- Written informed consent provided by the parent or legal guardian, and willingness of the participant to take part in the study
Key exclusion criteria (9 listed)
- Infection, ulcer, or scar tissue on the auricle
- Burn injury in the head and neck region that prevents application of the device to the auricular vagus nerve area
- Metallic implant in the skull, excessive sensitivity in the ear, ear injury, or ear inflammation
- Chronic pulmonary and/or cardiac disease
- Heart rate below 60 beats per minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Vagus Nerve StimulationNon-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. | Device | Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy |
| Conventional PhysiotherapyParticipants 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. | Other | Conventional Physiotherapy, Non-Invasive Vagus Nerve Stimulation Plus Conventional Physiotherapy |
Primary outcome
Change in anxiety level
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
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.
Change in sleep-related symptoms
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
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.
Change in pain intensity
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
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.
Change in pruritus severity
Time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks
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.
Change in Root Mean Square of Successive Differences
Time frame: Baseline and after completion of the 10-session treatment program, approximately 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
Time frame: Baseline and after completion of the 10-session treatment program, approximately 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
Time frame: Baseline and after completion of the 10-session treatment program, approximately 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sümeyye Akçay, Asst. Prof. principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Vagus Nerve Stimulation and Conventional Physiotherapy in people with Burn Injury, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety level (time frame: Baseline and after completion of the 10-session treatment program, approximately 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.