Burn InjuryNCT07566910
Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing
A study testing Non-Invasive Vagus Nerve Stimulation and Standard Dressing Care 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 on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Non-Invasive Vagus Nerve Stimulation and Standard Dressing Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Having superficial or deep second-degree burns requiring dressing during the acute period
- Expected to attend at least 7 dressing sessions
- Willing to participate in the study and able to provide written informed consent
- Able to read and understand Turkish
Who cannot join
- Infection, ulcer, or scar tissue on the auricle
- Burns in the head and neck region that prevent application of the device to the auricular vagus nerve area
- Metallic implant in the skull
- Excessive sensitivity, injury, or inflammation in the ear
- Chronic pulmonary and/or cardiac disease
- Heart rate below 60 beats per minute
Show all 10Show fewer
- Presence of a pacemaker or cochlear implant
- Uncontrolled hypertension
- Lack of cooperation
- Refusal or inability 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 Pain, Anxiety, and Quality of Life During the Dressing Process in Burn Patients: A Three-Group Comparative Intervention Study
This study will evaluate the effects of non-invasive vagus nerve stimulation on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. One group will receive non-invasive vagus nerve stimulation for 20 minutes before dressing, one group will receive non-invasive vagus nerve stimulation for 20 minutes during dressing, and the control group will receive standard dressing care only. Pain will be assessed using the Visual Analog Scale, anxiety will be assessed using the Beck Anxiety Inventory, and quality of life will be assessed using the SF-12 Health Survey. The study aims to determine whether non-invasive vagus nerve stimulation can reduce dressing-related pain and anxiety and improve quality of life in burn patients.
Read the detailed description
Burn injuries are associated with severe pain, psychological distress, and reduced quality of life. Dressing procedures may cause additional procedural pain and anxiety, which can negatively affect patient comfort, treatment adherence, and rehabilitation. Non-invasive vagus nerve stimulation is a neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This method may modulate autonomic nervous system activity and may have beneficial effects on pain and anxiety.
This randomized, three-group comparative interventional study will include adult burn patients who require repeated dressing procedures. A total of 96 participants will be included, with 32 participants in each group. Participants will be randomly assigned to one of three groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only.
In the first intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes before the dressing procedure. In the second intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes during the dressing procedure. In the control group, participants will receive only the standard dressing procedure without non-invasive vagus nerve stimulation.
For participants receiving non-invasive vagus nerve stimulation, electrodes will be placed on the tragus and the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes using a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. The stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. If the participant feels unwell during stimulation, the procedure will be stopped.
Participants are expected to undergo dressing procedures every other day for a total of seven sessions. Pain will be evaluated using the Visual Analog Scale before and after each dressing session. Anxiety will be evaluated using the Beck Anxiety Inventory, and quality of life will be evaluated using the SF-12 Health Survey before the first dressing session and before the seventh dressing session. The study will compare changes in pain, anxiety, and quality of life between the three groups.
- Conditions
- Burn Injury
- Being tested
- Non-Invasive Vagus Nerve Stimulation, Standard Dressing Care
- Keywords
- Burn patients, Burn dressing, Non-invasive vagus nerve stimulation, Pain, Anxiety, Quality of life
- Medical subject headings
- Burns, Pain, Anxiety Disorders
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 the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. The stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. If the participant feels unwell during stimulation, the procedure will be stopped.
Standard Dressing CareProcedure or surgery
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Vagus Nerve Stimulation Before Dressing | Experimental | Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care. Receives: Device: Non-Invasive Vagus Nerve Stimulation; Procedure: Standard Dressing Care |
| Non-Invasive Vagus Nerve Stimulation During Dressing | Experimental | Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care. Receives: Device: Non-Invasive Vagus Nerve Stimulation; Procedure: Standard Dressing Care |
| Standard Dressing Care | Active comparator | Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation. Receives: Procedure: Standard Dressing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Pain will be measured before and after each dressing session.
Measured: Before and after each dressing session through 7 dressing sessions, approximately 14 days
Change in Anxiety Level
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 higher levels of anxiety.
Measured: Before the first dressing session and before the seventh dressing session, approximately 14 days
Change in Quality of Life
Quality of life will be assessed using the SF-12 Health Survey. The SF-12 evaluates physical and mental health components of quality of life. Higher scores indicate better health-related quality of life.
Measured: Before the first dressing session and before the seventh dressing session, approximately 14 days
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 start4 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 three parallel groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only. Each participant will remain in the assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 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
- NCT07566910
- Sponsor's protocol ID
- KartalYanikH
- 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 because the study data will contain sensitive health-related information from burn patients. Data will be used only by the research team for the purposes of this study and will be reported in aggregate form 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 Pain, Anxiety, and Quality of Life During the Dressing Process in Burn Patients: A Three-Group Comparative Intervention Study
- ClinicalTrials.gov ID
- NCT07566910
- Acronym / sponsor ID
- KartalYanikH
- Conditions
- Burn Injury
- Keywords
- Burn patients, Burn dressing, Non-invasive vagus nerve stimulation, Pain, Anxiety, Quality of life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 4 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 on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. One group will receive non-invasive vagus nerve stimulation for 20 minutes before dressing, one group will receive non-invasive vagus nerve stimulation for 20 minutes during dressing, and the control group will receive standard dressing care only. Pain will be assessed using the Visual Analog Scale, anxiety will be assessed using the Beck Anxiety Inventory, and quality of life will be assessed using the SF-12 Health Survey. The study aims to determine whether non-invasive vagus nerve stimulation can reduce dressing-related pain and anxiety and improve quality of life in burn patients.
Detailed description
Burn injuries are associated with severe pain, psychological distress, and reduced quality of life. Dressing procedures may cause additional procedural pain and anxiety, which can negatively affect patient comfort, treatment adherence, and rehabilitation. Non-invasive vagus nerve stimulation is a neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This method may modulate autonomic nervous system activity and may have beneficial effects on pain and anxiety.
This randomized, three-group comparative interventional study will include adult burn patients who require repeated dressing procedures. A total of 96 participants will be included, with 32 participants in each group. Participants will be randomly assigned to one of three groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only.
In the first intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes before the dressing procedure. In the second intervention group, non-invasive vagus nerve stimulation will be applied for 20 minutes during the dressing procedure. In the control group, participants will receive only the standard dressing procedure without non-invasive vagus nerve stimulation.
For participants receiving non-invasive vagus nerve stimulation, electrodes will be placed on the tragus and the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes using a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. The stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. If the participant feels unwell during stimulation, the procedure will be stopped.
Participants are expected to undergo dressing procedures every other day for a total of seven sessions. Pain will be evaluated using the Visual Analog Scale before and after each dressing session. Anxiety will be evaluated using the Beck Anxiety Inventory, and quality of life will be evaluated using the SF-12 Health Survey before the first dressing session and before the seventh dressing session. The study will compare changes in pain, anxiety, and quality of life between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: non-invasive vagus nerve stimulation before dressing, non-invasive vagus nerve stimulation during dressing, or standard dressing care only. Each participant will remain in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Vagus Nerve Stimulation Before Dressing | Experimental | Device: Non-Invasive Vagus Nerve Stimulation, Procedure: Standard Dressing CareParticipants in this group will receive non-invasive vagus nerve stimulation for 20 minutes before each dressing procedure, in addition to standard dressing care. |
| Non-Invasive Vagus Nerve Stimulation During Dressing | Experimental | Device: Non-Invasive Vagus Nerve Stimulation, Procedure: Standard Dressing CareParticipants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care. |
| Standard Dressing Care | Active comparator | Procedure: Standard Dressing CareParticipants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 65 years
- Having superficial or deep second-degree burns requiring dressing during the acute period
- Expected to attend at least 7 dressing sessions
- Willing to participate in the study and able to provide written informed consent
- Able to read and understand Turkish
Key exclusion criteria (10 listed)
- Infection, ulcer, or scar tissue on the auricle
- Burns in the head and neck region that prevent application of the device to the auricular vagus nerve area
- Metallic implant in the skull
- Excessive sensitivity, injury, or inflammation in the ear
- Chronic pulmonary and/or cardiac disease
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 the inner and posterior surfaces of the concha of the external ear. Stimulation will be applied continuously for 20 minutes with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. The stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached. If the participant feels unwell during stimulation, the procedure will be stopped. | Device | Non-Invasive Vagus Nerve Stimulation Before Dressing, Non-Invasive Vagus Nerve Stimulation During Dressing |
| Standard Dressing CareParticipants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic. | Procedure or surgery | Non-Invasive Vagus Nerve Stimulation Before Dressing, Non-Invasive Vagus Nerve Stimulation During Dressing, Standard Dressing Care |
Primary outcome
Change in Pain Intensity
Time frame: Before and after each dressing session through 7 dressing sessions, approximately 14 days
Pain intensity will be assessed using the Visual Analog Scale. Participants will mark their pain level on a 100-mm line, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Pain will be measured before and after each dressing session.
Change in Anxiety Level
Time frame: Before the first dressing session and before the seventh dressing session, approximately 14 days
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 higher levels of anxiety.
Change in Quality of Life
Time frame: Before the first dressing session and before the seventh dressing session, approximately 14 days
Quality of life will be assessed using the SF-12 Health Survey. The SF-12 evaluates physical and mental health components of quality of life. Higher scores indicate better health-related quality of life.
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 because the study data will contain sensitive health-related information from burn patients. Data will be used only by the research team for the purposes of this study and will be reported in aggregate form 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 Standard Dressing Care 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 5 inclusion and 10 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 Pain Intensity (time frame: Before and after each dressing session through 7 dressing sessions, approximately 14 days). The study lists 3 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.