Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

Официальное название

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

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.

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.

Вмешательства

• Устройство Non-Invasive Vagus Nerve Stimulation
  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 stoppe
• Процедура Standard Dressing Care
  Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.

Первичные конечные точки

• Change in Pain Intensity [Срок оценки: Before and after each dressing session through 7 dressing sessions, approximately 14 days]
• Change in Anxiety Level [Срок оценки: Before the first dressing session and before the seventh dressing session, approximately 14 days]
• Change in Quality of Life [Срок оценки: Before the first dressing session and before the seventh dressing session, approximately 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Kartal Dr. Lütfi Kırdar City Hospital Burn Unit — Istanbul

Идентификаторы

NCT: NCT07566910 · KartalYanikH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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