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

17 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Turquia (Türkiye)
    • Beyoğlu
      • Istanbul, Beyoğlu, Turquia (Türkiye), 34421
        • Istanbul Health and Technology University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Experimental: 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.
Outro: 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 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.
Experimental: 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.
Outro: 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 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Autonomic Nervous System Assessment
Prazo: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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.
Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
Pulse Measurement
Prazo: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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.
Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
Blood Pressure Measurement
Prazo: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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.
Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Oxygen Saturation
Prazo: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.
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.
Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
State-Trait Anxiety Scale
Prazo: Baseline
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.
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Istanbul Health and Technology University

Investigadores

  • Diretor de estudo: Okan Şahin, PT, PhD, Istanbul Health and Technology University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de maio de 2026

Conclusão Primária (Real)

14 de agosto de 2026

Conclusão do estudo (Real)

15 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

10 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • OEZBP-2026

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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