Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07594873
Enrollment
30
Registered
2026-05-19
Start date
2026-05-02
Completion date
2026-08-15
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxious Individuals

Keywords

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

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.

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.

Interventions

OTHERControlled 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.

OTHERMusic-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.

Sponsors

Istanbul Health and Technology University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Autonomic Nervous System AssessmentBaseline, 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.
Pulse MeasurementBaseline, 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.
Blood Pressure MeasurementBaseline, 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.

Secondary

MeasureTime frameDescription
Oxygen SaturationBaseline, 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTOROkan Şahin, PT, PhD

Istanbul Health and Technology University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026