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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kartal
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Istanbul、Kartal、トルコ（Türkiye）、34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
アクティブコンパレータ：Standard Dressing Care
Participants in this group will receive standard dressing care only and will not receive non-invasive vagus nerve stimulation.
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Participants will receive standard burn wound dressing care according to the routine clinical procedures of the burn outpatient clinic.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity
時間枠：Before and after each dressing session through 7 dressing sessions, approximately 14 days
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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.
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Before and after each dressing session through 7 dressing sessions, approximately 14 days
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Change in Anxiety Level
時間枠：Before the first dressing session and before the seventh dressing session, approximately 14 days
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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.
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Before the first dressing session and before the seventh dressing session, approximately 14 days
|
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Change in Quality of Life
時間枠：Before the first dressing session and before the seventh dressing session, approximately 14 days
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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.
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Before the first dressing session and before the seventh dressing session, approximately 14 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sümeyye Akçay, Asst. Prof.、Fenerbahce University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KartalYanikH
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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