Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing
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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Kartal
-
Istanbul, Kartal, Турция (Туркие), 34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Presence of a pacemaker or cochlear implant
- Uncontrolled hypertension
- Lack of cooperation
- Refusal or inability to sign the informed consent form
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Non-Invasive Vagus Nerve Stimulation Before Dressing
Participants 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 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.
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
|
|
Экспериментальный: Non-Invasive Vagus Nerve Stimulation During Dressing
Participants in this group will receive non-invasive vagus nerve stimulation for 20 minutes during each dressing procedure, in addition to standard dressing care.
|
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.
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
|
|
Активный компаратор: Standard Dressing Care
Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.
|
Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Pain Intensity
Временное ограничение: 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.
|
Before and after each dressing session through 7 dressing sessions, approximately 14 days
|
|
Change in Anxiety Level
Временное ограничение: 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.
|
Before the first dressing session and before the seventh dressing session, approximately 14 days
|
|
Change in Quality of Life
Временное ограничение: 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.
|
Before the first dressing session and before the seventh dressing session, approximately 14 days
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sümeyye Akçay, Asst. Prof., Fenerbahce University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KartalYanikH
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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