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

May 17, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Beyoğlu
      • Istanbul, Beyoğlu, Turkey (Türkiye), 34421
        • Recruiting
        • Istanbul Health and Technology University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Nervous System Assessment
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation
Time Frame: 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Scale
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Health and Technology University

Investigators

  • Study Director: Okan Şahin, PT, PhD, Istanbul Health and Technology University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OEZBP-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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