The Acute Effects of Controlled Breathing Exercises and Music Therapy on the Autonomic Nervous System in Anxious Individuals

Официальное название

The Acute Effects of Controlled Breathing Exercises and Music Therapy on the Autonomic Nervous System in Anxious Individuals: A Randomized Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Controlled Breathing Exercises Group
  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
• Другое Music-Assisted Breathing Group
  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

Первичные конечные точки

• Autonomic Nervous System Assessment [Срок оценки: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.]
• Pulse Measurement [Срок оценки: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.]
• Blood Pressure Measurement [Срок оценки: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.]

Вторичные конечные точки (1)

• Oxygen Saturation [Срок оценки: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

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

• Istanbul Health and Technology University — Istanbul

Публикации

• Parizek D, Visnovcova N, Hamza Sladicekova K, Veternik M, Jakus J, Jakusova J, Visnovcova Z, Ferencova N, Tonhajzerova I. Effect of Selected Music Soundtracks on Cardiac Vagal Control and Complexity Assessed by Heart Rate Variability. Physiol Res. 2023 Nov 28;72(5):587-596. doi: 10.33549/physiolres.935114. PMID 38015758
• Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10. PMID 36630953
• Naci B, Demir R, Onder OO, Sinan UY, Kucukoglu MS. Effects of Adding Respiratory Training to Osteopathic Manipulative Treatment on Exhaled Nitric Oxide Level and Cardiopulmonary Function in Patients With Pulmonary Arterial Hypertension. Am J Cardiol. 2022 Jan 1;162:184-190. doi: 10.1016/j.amjcard.2021.09.023. Epub 2021 Oct 24. PMID 34706819
• Saoji AA, Raghavendra BR, Manjunath NK. Effects of yogic breath regulation: A narrative review of scientific evidence. J Ayurveda Integr Med. 2019 Jan-Mar;10(1):50-58. doi: 10.1016/j.jaim.2017.07.008. Epub 2018 Feb 1. PMID 29395894
• Lu G, Jia R, Liang D, Yu J, Wu Z, Chen C. Effects of music therapy on anxiety: A meta-analysis of randomized controlled trials. Psychiatry Res. 2021 Oct;304:114137. doi: 10.1016/j.psychres.2021.114137. Epub 2021 Jul 25. PMID 34365216
• Jerath R, Crawford MW, Barnes VA, Harden K. Widespread depolarization during expiration: a source of respiratory drive? Med Hypotheses. 2015 Jan;84(1):31-7. doi: 10.1016/j.mehy.2014.11.010. Epub 2014 Nov 18. PMID 25434482
• Park JI, Lee IH, Lee SJ, Kwon RW, Choo EA, Nam HW, Lee JB. Effects of music therapy as an alternative treatment on depression in children and adolescents with ADHD by activating serotonin and improving stress coping ability. BMC Complement Med Ther. 2023 Mar 6;23(1):73. doi: 10.1186/s12906-022-03832-6. PMID 36879223
• Chaitanya S, Datta A, Bhandari B, Sharma VK. Effect of Resonance Breathing on Heart Rate Variability and Cognitive Functions in Young Adults: A Randomised Controlled Study. Cureus. 2022 Feb 13;14(2):e22187. doi: 10.7759/cureus.22187. eCollection 2022 Feb. PMID 35308668

Идентификаторы

NCT: NCT07594873 · OEZBP-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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