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

NCT07594873 | Recruiting

• 1 other identifier: OEZBP-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxious Individuals

Keywords

Controlled Breathing; Music Therapy; Autonomic Nervous System; Vagal Activity

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Oxygen Saturation

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

Other Outcomes (1)

• State-Trait Anxiety Scale

  Baseline

Study Arms (3)

Control Group(CG)

NO INTERVENTION

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.

Controlled Breathing Exercises Group (CBE)

EXPERIMENTAL

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

Music-Assisted Breathing Group (MAB)

EXPERIMENTAL

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

Interventions

Controlled Breathing Exercises Group OTHER

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.

Controlled Breathing Exercises Group (CBE)

Music-Assisted Breathing Group OTHER

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.

Music-Assisted Breathing Group (MAB)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Health and Technology University: lead

Study Sites (1)

Istanbul Health and Technology University

Istanbul, Beyoğlu, 34421, Turkey (Türkiye)

RECRUITING

Related Publications (18)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

  RESULT

• 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.

  PMID: 37974551 RESULT

• 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.

  RESULT

• 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.

  PMID: 23538082 RESULT

• 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.

  PMID: 22178086 RESULT

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

  RESULT

• 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.

  PMID: 35259917 RESULT

• Göçen, H. B., & Özden, A. V. Psikiyatrik Bozukluklarda Otonom Disfonksiyon. cappsy.org/archives/vol16/no3/cap_16_03_02.pdf

  RESULT

• Coote JH. Recovery of heart rate following intense dynamic exercise. Exp Physiol. 2010 Mar;95(3):431-40. doi: 10.1113/expphysiol.2009.047548. Epub 2009 Oct 16.

  PMID: 19837772 RESULT

• Bonaz B, Bazin T, Pellissier S. The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Front Neurosci. 2018 Feb 7;12:49. doi: 10.3389/fnins.2018.00049. eCollection 2018.

  PMID: 29467611 RESULT

Study Officials

• Okan Şahin, PT, PhD

  Istanbul Health and Technology University

  STUDY DIRECTOR

Central Study Contacts

Gülce Esentürk, PhD, DMD

CONTACT

444 3 788; gulce.esenturk@istun.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individuals to be included in the study will be randomized into three groups as Control Group (CG), Controlled Breathing Exercises Group (CBE), or Music-Assisted Breathing Group (MAB) after the first evaluations are completed. Randomization will be done with the www.randomizer.com site. The groups of individuals determined according to the order of participation will be placed in opaque envelopes and the envelopes will be closed. On the same day, the physiotherapist, who will apply the intervention will do the application according to the group that comes out of the envelope. Post-intervention assessments for all participants will be conducted by the first physiotherapist, who will remain blinded to group assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT, PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 19, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

TU (1)