Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients
The Effects of Non-Invasive Vagus Nerve Stimulation on Anxiety, Sleep Quality, Pain, Itching, and Autonomic Functions in Burn Patients Aged 12-18
This study will evaluate the effects of non-invasive vagus nerve stimulation in adolescents aged 12 to 18 years who have burn injuries. The study will include patients who have completed the acute phase after burn injury and who have symptoms such as anxiety, sleep problems, pain, or itching.
Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy together with non-invasive vagus nerve stimulation. The other group will receive only conventional physiotherapy. The treatment program will be applied 5 days per week for a total of 10 sessions.
The study will assess whether non-invasive vagus nerve stimulation improves anxiety, sleep quality, pain, itching, and autonomic nervous system function. These outcomes will be measured before and after the treatment program using clinical scales and heart rate variability measurements.
調査の概要
詳細な説明
Burn injuries may cause long-term physical and psychological symptoms in pediatric and adolescent patients, including pain, itching, sleep problems, anxiety, and changes in autonomic nervous system activity. These symptoms may negatively affect recovery and rehabilitation outcomes.
Non-invasive vagus nerve stimulation is a transcutaneous neuromodulation method that stimulates the auricular branch of the vagus nerve through electrodes placed on the external ear. This stimulation may influence autonomic nervous system regulation and may have potential effects on pain, sleep, anxiety, itching, and physiological recovery.
This study is designed as a randomized interventional study. Adolescents aged 12 to 18 years with burn injuries will be randomly assigned to an intervention group or a control group. The intervention group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy. The control group will receive conventional physiotherapy only.
The non-invasive vagus nerve stimulation will be applied through electrodes placed on the tragus and concha regions of both ears. Stimulation will be delivered with a biphasic asymmetrical waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz. Each stimulation session will last 20 minutes. The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached. If the participant feels unwell during the stimulation, the procedure will be stopped.
Both groups will receive individualized conventional physiotherapy programs based on their clinical needs. These programs may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management. Conventional physiotherapy sessions will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
Outcome assessments will be performed before the start of treatment and after completion of the 10-session treatment program. Anxiety will be assessed using the Beck Anxiety Inventory. Sleep-related symptoms will be assessed using the Adolescent Insomnia Scale. Pain will be assessed using the 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 aim of the study is to determine whether non-invasive vagus nerve stimulation, when added to conventional physiotherapy, improves anxiety, sleep quality, pain, itching, and autonomic function in adolescents with burn injuries.
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
-
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
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Being between 12 and 18 years of age
- Having completed the acute phase after burn injury, with at least 1 month and at most 1 year since the burn injury
- Having second- or third-degree burns involving 5% to 30% of total body surface area
- Having at least one of the following complaints: anxiety, poor sleep quality, pain, or itching
- Written informed consent provided by the parent or legal guardian, and willingness of the participant to take part in the study
- Ability to read and understand Turkish
Exclusion Criteria:
- Infection, ulcer, or scar tissue on the auricle
- Burn injury in the head and neck region that prevents application of the device to the auricular vagus nerve area
- Metallic implant in the skull, excessive sensitivity in the ear, ear injury, or ear inflammation
- Chronic pulmonary and/or cardiac disease
- Heart rate below 60 beats per minute
- Presence of a pacemaker, cochlear implant, or similar implanted device
- Uncontrolled hypertension
- Lack of cooperation
- Refusal or inability of the parent or legal guardian 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 Plus Conventional Physiotherapy
Participants in this group will receive non-invasive vagus nerve stimulation in addition to conventional physiotherapy.
The treatment will be applied 5 days per week for a total of 10 sessions.
|
Non-invasive vagus nerve stimulation will be applied using electrodes placed on the tragus and concha regions of both ears.
Stimulation will be delivered with a biphasic asymmetrical waveform, a pulse duration of 300 microseconds, and a frequency of 25 Hz for 20 minutes.
The stimulation intensity will be gradually increased in 0.1 mA steps until the participant's sensory threshold is reached.
The intervention will be applied 5 days per week for a total of 10 sessions.
Participants will receive an individualized conventional physiotherapy program based on their clinical needs.
The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management.
Each session will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
|
|
アクティブコンパレータ：Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy only.
The treatment will be applied 5 days per week for a total of 10 sessions.
|
Participants will receive an individualized conventional physiotherapy program based on their clinical needs.
The program may include strengthening exercises, stretching exercises, balance exercises, active and passive range-of-motion exercises, and interventions for edema management.
Each session will last approximately 45 minutes and will be applied 5 days per week for a total of 10 sessions.
|
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 |
|---|---|---|
|
Change in anxiety level
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
Anxiety level will be assessed using the Beck Anxiety Inventory.
The scale consists of 21 items scored from 0 to 3, with a total score ranging from 0 to 63.
Higher scores indicate higher anxiety severity.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in sleep-related symptoms
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
Sleep-related symptoms will be assessed using the Adolescent Insomnia Scale.
The scale includes 13 items and evaluates sleep onset, sleep maintenance, and sleep dissatisfaction/disturbances.
Total scores range from 0 to 52, with higher scores indicating more severe insomnia symptoms.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in pain intensity
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
Pain intensity will be assessed using the Visual Analog Scale.
Participants will mark their pain level on a 100-mm line, where higher scores indicate greater pain intensity.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in pruritus severity
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
Pruritus severity will be assessed using the 12-Item Pruritus Severity Scale.
The scale evaluates the severity, frequency, duration, distribution, and impact of itching on daily life and sleep.
Higher scores indicate more severe pruritus.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in Root Mean Square of Successive Differences
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
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.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in Standard Deviation of Normal-to-Normal Intervals
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
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.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
|
Change in Low-Frequency/High-Frequency Ratio
時間枠：Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
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.
|
Baseline and after completion of the 10-session treatment program, approximately 2 weeks
|
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
追加の関連 MeSH 用語
その他の研究ID番号
- KartalYanık
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。