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Anxious IndividualsNCT07594873

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

A study testing Music-Assisted Breathing Group in people with Anxious Individuals, run by Istanbul Health and Technology University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Anxious Individuals
What is being tested?
Music-Assisted Breathing Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 May 2026to 15 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Health and Technology University

    Istanbul, Beyoğlu, 34421

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Controlled Breathing Exercises Group, Music-Assisted Breathing Group
Keywords
Controlled Breathing, Music Therapy, Autonomic Nervous System, Vagal Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Controlled Breathing Exercises GroupOther

    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.

  • Music-Assisted Breathing GroupOther

    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.

Study groups in NCT07594873
Study groupRoleWhat they receive
Control Group(CG)No interventionThe 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.
Controlled Breathing Exercises Group (CBE)ExperimentalControlled 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.
Receives: Other: Controlled Breathing Exercises Group
Music-Assisted Breathing Group (MAB)ExperimentalThe 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.
Receives: Other: Music-Assisted Breathing Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Autonomic Nervous System Assessment

    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.

    Measured: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

  2. Pulse Measurement

    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.

    Measured: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

  3. Blood Pressure Measurement

    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.

    Measured: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

Secondary outcomes (1)
  1. Oxygen Saturation

    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.

    Measured: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start2 May 2026
  3. Primary completion14 Aug 2026
  4. Study completion15 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will include individuals aged 18-40 who have moderate anxiety according to the State-Trait Anxiety Inventory and meet the inclusion criteria. Participants meeting the inclusion criteria (n=30) and completing the assessments will be randomized using www.randomizer.com into three groups: Control Group (CG) (n=10), Controlled Breathing Exercises Group (CBE) (n=10), and Music-Assisted Breathing Group (MAB) (n=10). All participants' demographic characteristics (age, gender, occupation, etc.) will be recorded using a demographic information form. The CG will receive no intervention. The CBE will perform controlled breathing exercises. The MAB will perform the same breathing exercises along with music. All assessments will be conducted before and after the exercises, and the data obtained will be recorded. All participant assessments will be conducted at the Manual Therapy Laboratory of Istanbul Health and Technology University.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07594873
Sponsor's protocol ID
OEZBP-2026
Status last verified
Apr 2026
First submitted
10 May 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35308668
  • Öner, N. Ve Le Compte, A. (1998). Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı (2. baskı). İstanbul: Boğaziçi Üniversitesi Yayınevi.

  • Hatik SH, Arslan M, Demirbilek O, Ozden AV. The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals. Brain Behav. 2023 Dec;13(12):e3332. doi: 10.1002/brb3.3332. Epub 2023 Nov 16.

    PubMed 37974551
  • Latha, R., Tamilselvan, K., Susiganeshkumar, E., & Sairaman, H. (2015). Effect of classical music on heart rate variability between genders. International Journal of Biomedical Research, 6(03), 192-195.

  • Brown RP, Gerbarg PL, Muench F. Breathing practices for treatment of psychiatric and stress-related medical conditions. Psychiatr Clin North Am. 2013 Mar;36(1):121-40. doi: 10.1016/j.psc.2013.01.001.

    PubMed 23538082
  • Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.

    PubMed 22178086
  • Tort, ABL; Brankačk, J.; Draguhn, A. Solunumla Eğitilen Beyin Ritmleri Küreseldir ancak Genellikle Gözden Kaçırılır. Trendler Nörobilim. 2018 , 41 , 186-197. [ Google Akademik ] [ CrossRef ]

  • Ashhad S, Kam K, Del Negro CA, Feldman JL. Breathing Rhythm and Pattern and Their Influence on Emotion. Annu Rev Neurosci. 2022 Jul 8;45:223-247. doi: 10.1146/annurev-neuro-090121-014424. Epub 2022 Mar 8.

    PubMed 35259917

Questions about this trial

What is this clinical trial studying?

A study testing Music-Assisted Breathing Group in people with Anxious Individuals, run by Istanbul Health and Technology University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autonomic Nervous System Assessment (time frame: Baseline, and at 0, 10, and 20 minutes after the 20-minute exercise session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07594873, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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