Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients
The Effect of Non-Invasive Vagus Nerve Stimulation on Anxiety, Sleep Quality, Pain, Itching, and Autonomic Function in Burn Patients
This study will evaluate the effects of non-invasive vagus nerve stimulation (nVNS) in adults with burn injuries. Burn patients may experience anxiety, poor sleep quality, pain, itching, and changes in autonomic nervous system function during recovery.
Participants will be randomly assigned to one of two groups. The intervention group will receive conventional physiotherapy plus nVNS, and the control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. nVNS will be applied through electrodes placed on the external ear for 20 minutes per session.
Anxiety, sleep quality, pain, itching, and autonomic function will be assessed before and after the treatment period. Autonomic function will be evaluated using heart rate variability measurements. The results will help determine whether nVNS may be a useful supportive method in the rehabilitation of burn patients.
調査の概要
詳細な説明
This study is a randomized controlled experimental study designed to investigate the effects of non-invasive vagus nerve stimulation (nVNS) on anxiety, sleep quality, pain, itching, and autonomic nervous system function in adults with burn injuries.
The study population will consist of patients followed at the Burn Outpatient Clinic of Kartal Dr. Lütfi Kırdar City Hospital in Istanbul, Türkiye. Eligible participants will be adults aged 18 to 65 years who have completed the acute phase of burn injury, whose burn injury occurred between 1 month and 1 year before enrollment, and who have second- or third-degree burns involving 5% to 30% of total body surface area. Participants must also report at least one complaint related to anxiety, sleep quality, pain, or itching and provide written informed consent.
A total of 60 participants are planned to be included. Participants will be randomly assigned in equal numbers to an intervention group or a control group. The intervention group will receive conventional physiotherapy and nVNS. The control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. Conventional physiotherapy will be planned according to each participant's needs and may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema. Each conventional physiotherapy session will last approximately 45 minutes.
In the intervention group, nVNS will be applied using electrodes positioned on the tragus and the anterior and posterior surfaces of the concha of the right and left external ear. Stimulation will be delivered 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 a participant feels unwell during stimulation, the procedure will be stopped.
Outcome assessments will be performed before treatment and after completion of the 10th session. Anxiety will be assessed using the Beck Anxiety Inventory. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Pain will be assessed using a 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 study aims to determine whether adding nVNS to conventional physiotherapy provides additional benefits for psychological symptoms, sleep quality, pain, itching, and autonomic function in burn rehabilitation.
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
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-
Kartal
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Istanbul、Kartal、トルコ（Türkiye）、34865
- Kartal Dr. Lütfi Kırdar City Hospital Burn Unit
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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:
- Adults aged 18 to 65 years
- Patients who have completed the acute phase of burn injury
- Burn injury occurred at least 1 month and no more than 1 year before enrollment
- Second- or third-degree burn involving 5% to 30% of total body surface area
- Presence of at least one complaint related to anxiety, sleep quality, pain, or itching
- Able to read and understand Turkish
- Willing to participate in the study
- Written informed consent provided
Exclusion Criteria:
- Infection, ulcer, or scar tissue on the auricle
- Burn injury in the head and neck region preventing application of the device over the auricular branch of the vagus nerve
- Metallic implant in the skull
- Excessive sensitivity, injury, or inflammation in the ear
- Chronic pulmonary disease and/or chronic cardiac disease
- Resting heart rate below 60 beats per minute
- Presence of a pacemaker, cochlear implant, or similar implanted device
- Uncontrolled hypertension
- Lack of cooperation or inability to comply with study procedures
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 |
|---|---|
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実験的：Conventional Physiotherapy Plus Non-Invasive Vagus Nerve Stimulation
Participants in this group will receive conventional physiotherapy plus non-invasive vagus nerve stimulation.
Treatment will be provided 5 days per week for a total of 10 sessions.
Conventional physiotherapy will last approximately 45 minutes per session.
Non-invasive vagus nerve stimulation will be applied to the external ear for 20 minutes per session.
|
Non-invasive vagus nerve stimulation will be applied using a Vagustim device.
Electrodes will be placed on the tragus and the anterior and posterior surfaces of the concha of both ears.
Stimulation will be applied continuously for 20 minutes per session with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz.
Stimulation intensity will be increased in 0.1 mA steps until the sensory threshold is reached.
The procedure will be stopped if the participant feels unwell.
Conventional physiotherapy will be planned according to each participant's needs and will be provided by a physiotherapist.
The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema.
Sessions will be performed 5 days per week for a total of 10 sessions, with each session lasting approximately 45 minutes.
|
|
アクティブコンパレータ：Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only.
Treatment will be provided 5 days per week for a total of 10 sessions.
Conventional physiotherapy will be planned according to each participant's needs and may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema.
|
Conventional physiotherapy will be planned according to each participant's needs and will be provided by a physiotherapist.
The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema.
Sessions will be performed 5 days per week for a total of 10 sessions, with each session lasting approximately 45 minutes.
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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 Anxiety Level
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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 greater anxiety severity.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Sleep Quality
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
The scale evaluates sleep quality and sleep disturbances over the previous month.
The total score ranges from 0 to 21, and higher scores indicate poorer sleep quality.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Pain Intensity
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Pain intensity will be assessed using a visual analog scale.
Participants will mark their pain level on a 100-mm line, where higher scores indicate greater pain intensity.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Pruritus Severity
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale.
The scale evaluates multiple aspects of itching, including location, duration, frequency, intensity, scratching behavior, emotional effects, sleep disturbance, daily activity effects, and quality-of-life impact.
Higher scores indicate more severe itching.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Root Mean Square of Successive Differences
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Standard Deviation of Normal-to-Normal Intervals
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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Change in Low-Frequency/High-Frequency Ratio
時間枠：Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.
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Baseline and after completion of 10 treatment sessions, up to 2 weeks
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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.、Fenerbahçe University
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- KartalHosp
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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