The Acute Effects of Controlled Breathing Exercises and Music Therapy on the Autonomic Nervous System in Anxious Individuals
2026年8月17日 更新者：Okan Sahin、Istanbul Health and Technology University
The Acute Effects of Controlled Breathing Exercises and Music Therapy on the Autonomic Nervous System in Anxious Individuals: A Randomized Controlled Study
This project aims to investigate the acute effects of controlled breathing exercises and music therapy on parasympathetic nervous system activation and increased heart rate variability in anxious individuals.
調査の概要
状態
完了
詳細な説明
The main objective of our project is to reduce the suppressive effect of stress on the parasympathetic nervous system and, accordingly, to increase heart rate variability in individuals with anxiety through controlled breathing exercises and music therapy applications. For this purpose, individuals aged between 18 and 40 years who have moderate anxiety levels according to the State-Trait Anxiety Inventory, who have not previously been diagnosed with any cardiovascular, respiratory, neurological, or psychiatric diseases, and who have not smoked for at least the past 6 months will be included in the study.
The individuals included in the study will be randomly assigned into three groups: a control group, a controlled breathing exercise group, and a music-supported breathing exercise group. At the baseline assessment, the State-Trait Anxiety Inventory will be used to determine the anxiety levels of all participants and to ensure group homogenization. In addition to determining anxiety levels at baseline, heart rate variability, blood pressure, heart rate, and oxygen saturation will be assessed in all groups.
No intervention will be applied to the control group; only assessments will be conducted. A single-session exercise protocol lasting 20 minutes will be applied to the breathing exercise group and the music-supported breathing exercise group. Heart rate variability will be measured using the Polar H9 device and Elite HRV software. Blood pressure and heart rate measurements will be performed using a digital blood pressure monitor. Oxygen saturation will be determined using a fingertip pulse oximeter.
The heart rate variability, blood pressure, heart rate, and oxygen saturation assessments performed at baseline will be repeated at the 0th, 10th, and 20th minutes after the completion of the exercise in the intervention groups. In the control group, participants will be asked to remain seated for 20 minutes, and following the completion of this period, the measurements performed at baseline will be repeated at the 0th, 10th, and 20th minutes. Thus, the final evaluation will be completed, and the obtained data will be analyzed.
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beyoğlu
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Istanbul、Beyoğlu、トルコ（Türkiye）、34421
- Istanbul Health and Technology University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Volunteer to participate in the study
- Not having a prior diagnosis of cardiovascular, respiratory, or neurological/psychiatric disease
- Not having a history of regular arrhythmias, pacemakers, or severe hypertension
- Not having smoked for at least 6 months
- Not having engaged in strenuous exercise in the last 24 hours
- Not having consumed caffeine/energy drinks within 6-8 hours prior to the intervention
- Being between 18 and 40 years of age
- Having a moderate level of anxiety according to the State-Trait Anxiety Scale
- Participants must be literate and have at least a high school diploma.
Exclusion Criteria:
- Having an active or chronic illness
- Experiencing cooperation problems
- Regular use of psychiatric medication (antidepressants, anxiolytics, etc.)
- Use of medications that affect heart rate, such as beta-blockers
- Auditory dysfunction (to the point of being unable to hear music)
- Individuals who are highly trained (very experienced) in breathing exercises or meditation
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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介入なし：Control Group(CG)
The control group will not receive any intervention.
Participants in this group will be asked to sit comfortably in a chair for a single 20-minute session.
Individuals will be provided with an environment where disturbing factors (sound, light) are prevented.
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実験的：Controlled Breathing Exercises Group (CBE)
Controlled breathing exercises will include resonant breathing, nadi shodhana, bhramari pranayama, and physiological sighing exercises.
Controlled breathing exercises will be performed in a single session lasting a total of 20 minutes.
Individuals will be provided with an environment where disturbing factors (sound, light) are prevented.
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Controlled breathing exercises include Resonance Breathing Exercises, Nadi Shodhana Pranayama, Bhramari Pranayama, and physiological sighing exercises.
The controlled breathing exercise group will receive these exercises in a single 20-minute session.
Resonance breathing will be practiced for 5 minutes at a rate of 6 breaths per minute.
During the intervention, patients will receive 2 sets of Nadi Shodhana Pranayama consisting of 8 breathing cycles, with a 2-minute rest period between sets.
The session will also include 2 sets of Bhramari Pranayama consisting of 8 breathing cycles at a low breathing rate, with a 1-minute rest period between sets.
The physiological sighing exercise involves an initial inhalation phase lasting 1 second, a second inhalation phase lasting 0.25 seconds, and an exhalation phase lasting 2 seconds, and is repeated for 5 minutes.
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実験的：Music-Assisted Breathing Group (MAB)
The music-assisted breathing exercise will perform the same breathing exercises (resonant breathing, nadi shodhana, bhramari pranayama, and physiological sighing) along with music.
Individuals will be provided with an environment where disturbing factors (sound, light) are prevented.
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The music-assisted breathing exercise will perform the same breathing exercises (resonant breathing, nadi shodhana, bhramari pranayama, and physiological sighing) along with music.
Music-assisted breathing exercise will be performed in a single session lasting a total of 20 minutes.
Music 1 (250-1000 Hz) and Music 2 (1000-16000 Hz) will be used at specific frequencies.
A slow, rhythmically consistent, vocalless basic melody will be selected within these frequency ranges.
The volume levels of all tracks will be kept constant.
The music will be played through stereo headphones.
Participants will listen to Music 1 (250-1000 Hz) for 10 minutes and Music 2 (1000-16000 Hz) for another 10 minutes.
Individuals will be provided with an environment where disturbing factors (sound, light) are prevented.
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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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Autonomic Nervous System Assessment
時間枠：Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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To assess the autonomic nervous system, heart rate variability will be evaluated.
A Polar H9 heart rate sensor chest strap and Elite HRV software will be used to measure analytical heart rate variability.
During the assessment, the participant will be in a seated position in a chair, the Polar system chest strap will be placed directly over the sternum, and ultrasound gel will be used to increase the conductivity of the sensor.
This method has validity with electrocardiogram.
Heart rate variability parameters such as RMSSD, PNN50, and LF/HF will be measured.
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Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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Pulse Measurement
時間枠：Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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Pulse measurements will be performed using an Omron brand digital blood pressure monitor.
Individuals will be rested for at least 5 minutes before the measurement to ensure relaxation for an accurate reading.
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Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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Blood Pressure Measurement
時間枠：Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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Blood pressure measurements will be performed using an Omron brand digital blood pressure monitor.
Individuals will be rested for at least 5 minutes before the measurement to ensure relaxation for an accurate reading.
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Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Oxygen Saturation
時間枠：Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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Pulse oximetry is a non-invasive, painless, and reliable method used to measure oxygen saturation (SpO2) in arterial blood.
Oxygen saturation measurement will be performed with a finger-type pulse oximeter device.
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Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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State-Trait Anxiety Scale
時間枠：Baseline
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To determine the anxiety level of all participants and to ensure group homogeneity, the State-Trait Anxiety Scale will be used.
Individuals with moderate anxiety according to the State-Trait Anxiety Scale will be included in the study.
This scale aims to assess the intensity of the emotions or behaviors expressed in the items on the scale.
Theoretically, scores on this scale can range from 20 to 80.
A higher score indicates a high level of anxiety, while a lower score indicates a low level of anxiety.
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Baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Okan Şahin, PT, PhD、Istanbul Health and Technology University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月2日
一次修了 (実際)
2026年8月14日
研究の完了 (実際)
2026年8月15日
試験登録日
最初に提出
2026年5月10日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年4月1日
詳しくは
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キーワード
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- OEZBP-2026
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米国FDA規制医薬品の研究
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米国FDA規制機器製品の研究
いいえ
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